1. Home
  2. Approved trials
  3. » فارسی

effect of progesterone in natural frozen – thawed embryo transfer cycles

 View older revisions Content changed at 2021-03-27, 1400/01/07

Protocol summary

Study aim
Better endometrial development and increased pregnancy rate
Design
A clinical trial with a randomized parallel control group with 102 patients. Participants participated in the study between March 2011 and March 2012 and were followed up to 20 weeks of gestation.
Settings and conduct
En Yazd Research and Clinical Center for infertility affiliated to Shahid Sadoughi University of Medical Sciences
Participants/Inclusion and exclusion criteria
Inclusion critera: cryopreserved embryos after conventional in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI); maternal age of 20-40 years (on the day of embryo freezing); regular menstrual cycle of 25-35 days; body mass index of 20-27 kg/m2 Exclusion critera:the use of testicular sperm for ICSI (ejaculated sperm only); basal follicle stimulating hormone; stage III-IV endometriosis; polycystic ovarian syndrome (PCOS)
Intervention groups
The progesterone group received 100mg/day of progesterone (Aburaihan Pharmaceutical Co., Tehran, Iran) IM, that began 36 hours after the hCG administration and continued until ten weeks of gestation if pregnancy occurred. Control patients received no progesterone. In both groups, cryopreserved embryo transfer was performed with a Cook catheter (Cook Ireland Ltd.) five days after hCG administration. Serum β-hCG level was measured 14 days after the transfer.
Main outcome variables
The main outcome measures concerned clinical pregnancy and implantation rates

General information

Reason for update
update as result
Acronym
IVF
IRCT registration information
IRCT registration number: IRCT201108044339N6
Registration date: 2011-09-22, 1390/06/31
Registration timing: registered_while_recruiting

Last update: 2021-03-27, 1400/01/07
Update count: 2
Registration date
2011-09-22, 1390/06/31
Registrant information
Name
Elham Rahmani
Name of organization / entity
Bushehr University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 77125265914
Email address
rahmani@bpums.ac.ir
Recruitment status
Recruitment complete
Funding source
Yazd research and clinical center for infertility
Expected recruitment start date
2011-03-01, 1389/12/10
Expected recruitment end date
2011-11-02, 1390/08/11
Actual recruitment start date
2011-03-01, 1389/12/10
Actual recruitment end date
2011-11-02, 1390/08/11
Trial completion date
2012-03-30, 1391/01/11
Scientific title
effect of progesterone in natural frozen – thawed embryo transfer cycles
Public title
natural frozen – thawed embryo transfer cycles
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
cryop reserved embryos after conventional in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) maternal age of 20-40 years (on the day of embryo freezing) regular menstrual cycle of 25-35 days body mass index of 20-27 kg/m2
Exclusion criteria:
the use of testicular sperm for ICSI (ejaculated sperm only) basal follicle stimulating hormone stage III-IV endometriosis polycystic ovarian syndrome (PCOS)
Age
From 20 years old to 40 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 109
Actual sample size reached: 102
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were randomized to either group in a ratio of 1:1 by means of computer-generated random numbers on the day of participation. Group selection and randomization were performed by a nurse not involved in the study, by using opaque sealed envelopes. Both the patients and the clinicians were aware of the allocated arm.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Yazd research and clinical center for infertility
Street address
Yazd research and clinical center for infertility, Booali Street, Safaieh, Yazd
City
Yazd
Province
Yazd
Postal code
8916877391
Approval date
2011-06-20, 1390/03/30
Ethics committee reference number
929

Health conditions studied

1

Description of health condition studied
female infertility
ICD-10 code
N97
ICD-10 code description
female infertility

Primary outcomes

1

Description
chemical pregnancy
Timepoint
14 days after embryo transfer
Method of measurement
BHCG TEST

Secondary outcomes

1

Description
Clinical pregnancy
Timepoint
4-5 weeks after embryo transfer
Method of measurement
Obestetrics sonography

2

Description
implantation rates
Timepoint
Five weeks after embryo transfer
Method of measurement
The number of pregnancy sacs divided by the number of transferred embryos multiplied by 100

3

Description
Clinical abortion
Timepoint
before20 weeks of gestation
Method of measurement
as clinically

Intervention groups

1

Description
On the second or third days of the menstrual cycle, all patients underwent transvaginal ultrasounds and serum hormone analysis for FSH. Then, a vaginal ultrasonographic examination was performed on cycle days 10 and repeated as necessary. Final oocyte maturation was achieved by intramuscular (IM) administration of 10000 IU of hCG (Pregnyl, Daropakhsh, Iran) when an endometrial thickness of 8 mm or more and a follicle of 18 mm were present on the ultrasound. On the day of the hCG administration, we measured serum estradiol‚ progesterone and LH levels.The progesterone group received 100mg/day of progesterone (Aburaihan Pharmaceutical Co., Tehran, Iran) IM, that began 36 hours after the hCG administration and continued until ten weeks of gestation if pregnancy occurred. In both groups, cryopreserved embryo transfer was performed with a Cook catheter (Cook Ireland Ltd.) five days after hCG administration. Serum β-hCG level was measured 14 days after the transfer.
Category
Treatment - Drugs

2

Description
In control group :On the second or third days of the menstrual cycle, all patients underwent transvaginal ultrasounds and serum hormone analysis for FSH. Then, a vaginal ultrasonographic examination was performed on cycle days 10 and repeated as necessary. Final oocyte maturation was achieved by intramuscular (IM) administration of 10000 IU of hCG (Pregnyl, Daropakhsh, Iran) when an endometrial thickness of 8 mm or more and a follicle of 18 mm were present on the ultrasound. On the day of the hCG administration, we measured serum estradiol‚ progesterone and LH levels.Control patients received no progesterone. In both groups, cryopreserved embryo transfer was performed with a Cook catheter (Cook Ireland Ltd.) five days after hCG administration. Serum β-hCG level was measured 14 days after the transfer.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Yazd research and clinical center for infertility
Full name of responsible person
Dr Maryam Eftekhar
Street address
Yazd research and clinical center for infertility, Booali Street, Safaieh, Yazd
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Fax
+98 35 3824 7085
Email
eftekhar@ssu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Vice-Chancellor for Research & Technology
Street address
Yazd research and clinical center for infertility, Booali Street, Safaieh, Yazd
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Fax
+98 35 3824 7085
Email
Eftekhar@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr Mozhgan Rahsepar
Position
Obestetrics and Gynecologist,Student of fellowship
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Yazd research and clinical center for infertility, Booali Street, Safaieh, Yazd
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 1824 7085
Fax
+98 35 1824 7085
Email
drrahsepar@hotmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr Maryam Eftekhar
Position
Obestetrics and Gynecologist, fellowship of infertility
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Yazd research and clinical center for infertility, Booali Street, Safaieh, Yazd
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 1824 7085
Fax
+98 35 1824 7085
Email
eftekharmaryam@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr.Maryam Eftekhar
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Boali Street, Safaieh, Yazd, Research and clinical center
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 1824 7085
Email
eftekhar@ssu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Information on the main outcome
When the data will become available and for how long
6 months after printing the results
To whom data/document is available
Editor-in-Chief
Under which criteria data/document could be used
use in the retrospective study
From where data/document is obtainable
Yazd research and clinical center for infertility
What processes are involved for a request to access data/document
Request from the Research Deputy, submitted to the Research Council of the Center if the request accepts its referral to the security and after completion of the relevant forms, request is referred to the research experts and then get the data.
Comments

Trial results

Please tick if results have been published
Yes
Summary result posting date
2021-03-08, 1399/12/18
Table of baseline comparison

Table 1

Characteristics of patients

Outcome variable Progesterone N=51 No progesterone N=51 P value
Age (Years) 29.0 ± 3.8 28.7 ± 4.6 0.71
BMI (kg/m2) 23.8 ± 2.8 24.3 ± 2.4 0.35
Duration of infertility (Years) 6.0 ± 3.8 6.7 ± 4.5 0.71
Basal FSH (IU/L) 5.8 ± 1.9 6.0 ± 2.0 0.90
Previous ART attempts n (%) 14 (27.5) 17 (33.3) 0.51
Etiology of infertility n (%) 0.62
Male factor 35 (68.6) 32 (62.7)
Tubal factor 7 (13.8) 6 (11.8)
Unexplained 9 (17.6) 13 (25.5)

Participant flow diagram

 

 

Table of variable outcomes' results

Table 2

Patients’ previous fresh cycle characteristics

Outcome variable Progesterone N=51 No progesterone N=51 P value
Type of previous stimulation n (%) 0.84
Agonist protocol 29 (56.9) 31(60.8)
Antagonist protocol 22 (43.1) 20 (39.2)
Fertilization procedure n (%)
IVF 11 (21.6) 19 (37.3)
ICSI 40 (78.4) 32 (62.7)
No. of oocytes retrieved 10.0 ± 4.3 9.6 ± 3.4 0.16
No. of mature oocytes 8.3 ± 3.4 7.6 ± 2.8 0.22
No. of embryos obtained 6.2 ± 1.6 5.7 ± 2.2 0.19
No. of embryos vitrified 4.3 ± 1.0 4.0 ± 0.6 0.07
Fertilization rate (%) 55.4 64.3 0.16
Sperm parameters
Count (mill/ml) 12.6 ± 7.7 11.9 ± 7.0 0.62
Progressive motility (%) 15.0 ± 5.8 14.5 ± 6.9 0.72
Normal morphology (%) 15.3 ± 9.8 14.2 ± 7.3 0.51
Cause of embryo freezing n (%) 0.59
Surplus embryos 30 (58.8) 26 (45.1)
Risk of OHSS 19 (37.3) 21(41.2)
Endometrial polyp 2 (3.9) 4 (7.8)

Table 3

Frozen-thawed embryo replacement cycle characteristics

Outcome variable Progesterone N=51 No progesterone N=51 P value
Endometrial thickness (mm) 8.7 ± 1.3 8.9 ± 1.4 0.64
E2 on hCG day (pg/ml) 208.4 ± 60.2 median: 200 196.9 ± 85.3 median: 170 0.11
Progesterone on hCG day (ng/ml) 0.77 ± 0.09 0.80 ± 0.07 0.08
LH on hCG day (IU/L) 4.9 ± 1.9 4.6 ± 1.7 0.39
No. of days until hCG 14.3 ± 1.8 13.7 ± 1.5 0.07
No. of embryos transferred 1.7 ± 0.5 median: 2 1.9 ± 0.5 median: 2 0.07
Transfers with good quality embryos (%) 54.9 60.8 0.54

Table 4

Pregnancy outcomes

Outcome variable Progesterone N=51 No progesterone N=51 P value
Chemical pregnancy rate‚ n (%) 18 (35.3) 16 (31.4) 0.83
Clinical pregnancy rate‚ n (%) 17 (33.3) 14 (27.5) 0.66
Implantation rate (%) 16.6 15.3 0.93
Clinical abortion rate‚ n (%) 2 (11.8) 2 (14.3) 0.83

Table of adverse events
First publication date
2013-04-01, 1392/01/12
Abstract of published paper
Abstract Background: The transfer of cryopreserved embryos can be timed with ovulation in a natural cycle or after artificially preparing the endometrium with exogenous hormones. Progesterone is essential for the secretory transformation of the endometrium that permits implantation as well as maintenance of early pregnancy. The purpose of this study is to assess the effect of luteal phase supplementation on pregnancy rates in natural frozen-thawed cycles. Materials and Methods: The study was designed as a prospective randomized clinical trial of 102 women who underwent embryo transfers in natural cycles. The women in the interventional group (n=51) received intra muscular (IM) progesterone 50 mg twice a day starting from 36 hours after hCG administration. The control group (n=51) did not receive any progesterone support. Results: There were no significant differences in demographic characteristics between the groups and no statistically significant differences were observed between study and control groups in clinical pregnancy rate (33.3% vs. 27.5%, p=0.66). There were no differences in implantation rate or spontaneous abortion rate. Conclusion: Our results suggest that luteal phase support does not affect clinical pregnancy rates in natural frozen-thawed embryo transfer cycles (Registration Number: IRCT201108044339N6).
Loading...