We aim to evaluated the success rate of ongoing pregnancy in cases group with discontinue of luteal phase estrogen in women undergone artificial frozen embryo transfer (FET). The study population is women who referred to Royan Institute. In this study, one hundred women were participated in each group (case and control). This study is a randomized clinical trial-phase III, double blind and blocking at the observation of gestational sac with heart beat (6 weeks of pregnancy) by ultrasound. Artificial standard long GnRH agonist protocol use for endometrial preparation. In 2-3 days of the embryo transfer cycle, the patients will receive 6mg oral estradiol that will be continued for 14 days and if endometrial thickness estimated ≥7mm, intramuscularly progesterone 100 mg daily will be started for luteal phase support. Three or four days after the onset of progesterone, 2 to 3 frozen embryos will be transferred. Participants have 21-37 years old and surplus embryos from the IVF/ICSI cycles. Control group receive estrogen and progesterone from embryo transfer until 12 week of pregnancy and cases women will discontinued estrogen after observation of gestational sac with heart beat, while progesterone will remain daily use until twelfth week of pregnancy. We assessed ongoing clinical pregnancy (6 and 12 pregnancy week) and maternal levels of estrogen and progesterone at the time of the starting day of progesterone (day 15), the day of embryo transfer, 6 and 12 weeks of pregnancy.
General information
Acronym
Luteal phase support in frozen embryo transfer cycles
IRCT registration information
IRCT registration number:IRCT201611011141N24
Registration date:2017-02-01, 1395/11/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-02-01, 1395/11/13
Registrant information
Name
Kiandokht Kiani
Name of organization / entity
Royan Institute
Country
Iran (Islamic Republic of)
Phone
+98 21 2230 7960
Email address
kiandokht.kiani@royaninstitute.org
Recruitment status
Recruitment complete
Funding source
Royan Institute
Expected recruitment start date
2016-05-21, 1395/03/01
Expected recruitment end date
2017-06-22, 1396/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Duration of estrogen for luteal phase in pregnant women undergone frozen embryo transfer cycles- Randomized controlled trials Phase III
Public title
Luteal phase support during frozen embryo transfer cycle
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with surplus embryos undergone infertility treatment cycles (e.g. OHSS, inadequate endometrium, surplus frozen embryo from any cause); Age 21-37 years; Normal BMI (18.5 <BMI <30); IVF / ICSI or IVF or ICSI cycles with antagonists or agonists protocols; Frozen embryos on 2-3 days.
Exclusion criteria: Endometrial thickness ≤7mm; Egg Donors; Surrogacy; Male factor infertility with azoospermia; Age <37 years old; Hydrosalpinx; Uterine anomalies; Myoma with a compression effect or submocusa myoma; PGD; Blastocyst embryo transfer, ZIFT and GIFT.
Age
From 21 years old to 37 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
This study is a randomized clinical trials-phase III, double blind and blocking at the observation of gestational sac with heart beat (6 weeks of pregnancy) by ultrasound.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Royan Institute
Street address
Royan Institute, East Hafez Avenue, Bani Hashem Street, Resalat high way, Tehran, Iran
City
Tehran
Postal code
Approval date
2016-08-09, 1395/05/19
Ethics committee reference number
IR.ACECR.ROYAN.REC.1395.70
Health conditions studied
1
Description of health condition studied
Female infertility, unspecified
ICD-10 code
N97.9
ICD-10 code description
Female infertility, unspecified
Primary outcomes
1
Description
Ongoing pregnancy rate
Timepoint
6 & 12 weeks of pregnancy
Method of measurement
ultrasonography
Secondary outcomes
1
Description
Estrogen
Timepoint
start using progesterone for luteal support in FET cycle (day 15), the day of embryo transfer, 6 and 12 weeks of pregnancy
Method of measurement
Blood serum level
2
Description
Progesterone
Timepoint
start using progesterone for luteal support in FET cycle (day 15), the day of embryo transfer, 6 and 12 weeks of pregnancy
Method of measurement
Blood serum level
Intervention groups
1
Description
Discontinued of estrogen in luteal phase support in 6 week of pregnancy and fetal heart beat
Category
Treatment - Drugs
2
Description
No intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Royan Institute
Full name of responsible person
Dr Firoozeh Ghafari
Street address
Royan Institute, East Hafez Avenue, Bani Hashem Street, Resalat high way, Tehran, Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Royan institute, Vice chancellor for research
Full name of responsible person
Dr Firoozeh Ghafari
Street address
Royan Institute, East Hafez Avenue, Bani Hashem Street, Resalat high way, Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Royan institute, Vice chancellor for research
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Royan Institute
Full name of responsible person
Dr Abdolhoseyn Shahverdi
Position
PHD of Anatomy, Vice chancellor for research
Other areas of specialty/work
Street address
Royan Institute, East Hafez Avenue, Bani Hashem Street, Resalat high way, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 2230 6481
Fax
Email
shahverd2002@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Royan Institute
Full name of responsible person
Dr Firoozeh Ghafari
Position
Obstetrician and Gynecologist and Infertility, ART fellowship
Other areas of specialty/work
Street address
Royan Institute, East Hafez Avenue, Bani Hashem Street, Resalat high way, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 2356 2645
Fax
Email
Ghafaryf@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Royan Institute
Full name of responsible person
Zahra Chekini
Position
M.Sc. In Genetics / Major Collaborator
Other areas of specialty/work
Street address
Royan Institute, East Hafez Avenue, Bani Hashem Street, Resalat high way, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 2356 2645
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)