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Comparing pregnancy rate in GnRH agonist and letrozole plus gonadotropins protocol for endometrial preparation for frozen embryo transfer

Protocol summary

Summary
The purpose of this study is to compare the pregnancy rate in GnRH agonist protocol and letrozole plus gonadotropins protocol for endometrial preparation for frozen embryo transfer. Our main objective is pregnancy rate. The sample includes all women aged 18 to 42 years who undergoing endometrial preparation for frozen embryo transfer. Infertile couples with male infertility which undergo TESE or PESA, severe endometriosis (stage 3 or 4); uterine myoma with 4cm size or greater and fresh embryo transfer are excluded from the study. The sample includes 100 patients who are divided in two groups randomly. First group receives GnRH Agonist (Bucerelin, Aventis, Germany) 500 μg subcutaneously from previous midluteal cycle (21th day). Then Estradiol valerat (Daroopakhsh, Iran, 2 mg) daily oral is started on second day and is increased until the observation of 8mm endometrial thickness in transvaginal ultrasound. For visualizing endometrial thickness, Trans vaginal ultrasound (Sonoline G20; Siemens Medical Solutions, California, USA) is performed every 4 days. After the observation of at least 8mm endometrial thickness, Progesterone (Cyclogest, Germany, 800 mg) is started vaginally. After 3 days, Trans cervical embryo transfer will be carried out on day 16 to 19. Second group, receives letrozole (Iranhormone, Iran, 5mg daily) orally on 2th day of cycle for five days. Then HMG (Ferring, Germany, 75IU daily) is started on 7 day. After the observation of 18mm follicle in transvaginal ultrasound, HCG (Ferring, Germany, 10000IU, and IM) is injected for ovulation induction. Trans cervical embryo transfer is performed on day 16 to 19. Detection of chemical pregnancy is through serum BhCG analysis, 16 days after frozen embryo transfer and the clinical pregnancy is detected by the aid of trans vaginal ultrasound, two weeks later when the pregnancy sac is detected. Main outcome is chemical pregnancy rate. The rate of clinical pregnancy and implantation are compared between two groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201306256689N3
Registration date: 2013-12-31, 1392/10/10
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-12-31, 1392/10/10
Registrant information
Name
Sedigheh Hosseinimousa
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8800 8810
Email address
hoseinimosa@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Tehran University of Medical Sciences
Expected recruitment start date
2012-08-26, 1391/06/05
Expected recruitment end date
2013-12-26, 1392/10/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing pregnancy rate in GnRH agonist and letrozole plus gonadotropins protocol for endometrial preparation for frozen embryo transfer
Public title
Comparing two protocols for endometrial preparation for frozen embryo transfer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Infertile women 18-42 years old with freeze embryo Exclusion Criteria: 1- Male infertility which needs interventions such as TESE (Testicular Sperm Extraction) or PESA (Percutaneous Epididymal Sperm Aspiration) 2- Endometriosis (stage 3 or 4) 3- Uterine myoma with 4cm size or greater 4- Maternal age greater than 42 years old 5- Fresh embryo
Age
From 18 years old to 42 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
All patients sign informed consents forms. The sample included 100 patients who are divided in two groups randomly based in Bernoli distribution.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Ethics Committee, Tehran University of Medical Sciences, Poorsina Street, Tehran
City
Tehran
Postal code
1417653761
Approval date
2012-05-22, 1391/03/02
Ethics committee reference number
90-04-30-15625-53627

Health conditions studied

1

Description of health condition studied
Infertility
ICD-10 code
N97.4
ICD-10 code description
Female infertility associated with male factors

Primary outcomes

1

Description
Chemical Pregnancy
Timepoint
16 days after embryonal transfer
Method of measurement
βhCG titration

Secondary outcomes

1

Description
Clinical pregnancy
Timepoint
30 days after embryonal transfer
Method of measurement
Observed gestational sac in transvaginal sonography

2

Description
Implantation Rate
Timepoint
30 days after embryonal transfer
Method of measurement
The number of observed gestational sac in transvaginal sonography / the number of transferred embryos * 100

Intervention groups

1

Description
First group receives GnRH Agonist (Bucerelin, Aventis, Germany) 500 μg subcutaneously from previous midluteal cycle (21th day). Then Estradiol valerat (Daroopakhsh, Iran, 2 mg) daily oral is started on second day and is increased until the observation of 8mm endometrial thickness in transvaginal ultrasound. For visualizing endometrial thickness, Trans vaginal ultrasound (Sonoline G20; Siemens Medical Solutions, California, USA) is performed every 4 days. After the observation of at least 8mm endometrial thickness, Progesterone (Cyclogest, Germany, 800 mg) is started vaginally. After 3 days, Trans cervical embryo transfer will be carried out on day 16 to 19.
Category
Treatment - Drugs

2

Description
Second group, receives letrozole (Iranhormone, Iran, 5mg daily) orally on 2th day of cycle for five days. Then HMG (Ferring, Germany, 75IU daily) is started on 7 day. After the observation of 18mm follicle in transvaginal ultrasound, HCG (Ferring, Germany, 10000IU, and IM) is injected for ovulation induction. Trans cervical embryo transfer is performed on day 16 to 19.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Infertility Unit, Shariati Hospital
Full name of responsible person
Dr Sedighe Hoseinimosa
Street address
Department of Infertility, Shariati Hospital, Tehran University of Medical Sciences, North Karegar Street
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research, Tehran University of Medical Sciences
Full name of responsible person
Dr Masood Yunesian
Street address
Vice Chancellor for Research, Tehran University of Medical Sciences, Keshavarz Boulevard, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Tehran University of Medical Sciences
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
Tehran University of Medical Sciences, Shariati Hospital, Department of Infertility
Full name of responsible person
Dr Sedighe Hoseinimosa
Position
Infertility Fellowship
Other areas of specialty/work
Street address
Infertility Department, Shariati Hospital, North Karegar Street, Tehran
City
Tehran
Postal code
1411713135
Phone
+98 21 8800 8810
Fax
+98 21 8822 0050
Email
hoseinimosa@razi.tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Professor Ashraf Aleyasin
Position
Professor
Other areas of specialty/work
Street address
Infertility Department, Shariati Hospital, North Karegar Street, Tehran
City
Tehran
Postal code
1411713135
Phone
+98 21 8800 8810
Fax
+98 21 8822 0050
Email
Aleyasin@sina.tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Sedighe Hoseinimosa
Position
Infertility Fellowship
Other areas of specialty/work
Street address
Infertility Unit, Shariati Hospital, North Karegar Street, Tehran
City
Tehran
Postal code
1411713135
Phone
+98 21 8800 8810
Fax
+98 21 8822 0050
Email
hoseinimosa@razi.tums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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