GnRH Agonist Plus Hormone Replacement Therapy vs Hormone Replacement Therapy on IVF Outcomes
Primary Purpose
Polycystic Ovary Syndrome, Infertility, Female
Status
Completed
Phase
Phase 3
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Long GnRH agonist + HRT
HRT
Sponsored by
About this trial
This is an interventional treatment trial for Polycystic Ovary Syndrome
Eligibility Criteria
Inclusion Criteria:
The first or second cycle of embryo transfer Normal uterine cavity PCO diagnosis based on Rotterdam criteria and correction (2018) Age 20 to 40 years
Exclusion Criteria:
Infertility with severe male factor endometriosis immunological disease FSH higher than 10 BMI greater than or equal to 30 Endometrial thickness on the day of transfer is less than 7 mm History of recurrent miscarriage
Sites / Locations
- Arash women's hospital,Tehran university of medical sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
HRT
Long GnRH agonist + HRT
Arm Description
HRT protocol : estradiol and progesterone
Long GnRH agonist + HRT protocol: Superfect and estradiol and progesterone
Outcomes
Primary Outcome Measures
Endometrial thickness
Endometrial thickness on the day of transfer will be measured by transvaginal ultrasound
Chemical pregnancy
A positive beta hCG levels
Clinical pregnancy
The gestational sac will be observed by Ultrasonography
Secondary Outcome Measures
Full Information
NCT ID
NCT05189873
First Posted
December 11, 2021
Last Updated
January 12, 2022
Sponsor
Tehran University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT05189873
Brief Title
GnRH Agonist Plus Hormone Replacement Therapy vs Hormone Replacement Therapy on IVF Outcomes
Official Title
Comparison of the Pregnancy Outcomes in Patients With the Polycystic Ovarian Syndrome in Two Endometrial Preparation Method GnRH Agonist Plus Hormone Replacement Therapy Versus Hormone Replacement Therapy in Frozen Embryo Transfer Cycle
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
June 10, 2021 (Actual)
Primary Completion Date
January 3, 2022 (Actual)
Study Completion Date
January 3, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tehran University of Medical Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The study is conducted at Arash Women's Hospital on all women undergoing the frozen embryo transfer cycle. Patients who signed informed consent will be randomly divided into two groups. The first group will receive GnRH agonist plus hormone replacement therapy for endometrial preparation. Group 2 will receive hormone replacement therapy. The random allocation and final outcome of the study will be assessed by a person who is unaware of the study process. Also, the statistician will be unaware of the study process
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome, Infertility, Female
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Masking Description
The randomization list will be prepared by a statistician using the block randomization method (using the site:www.sealedenvelope.com). Treatments are placed in sealed envelopes and will be kept by the out-of-study nurse. After identification of the eligibility of the patient, the procedure is explained to her and informed consent is obtained. Then the treatment is performed based on the kind of treatment in the envelope.
Allocation
Randomized
Enrollment
128 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HRT
Arm Type
Experimental
Arm Description
HRT protocol : estradiol and progesterone
Arm Title
Long GnRH agonist + HRT
Arm Type
Experimental
Arm Description
Long GnRH agonist + HRT protocol: Superfect and estradiol and progesterone
Intervention Type
Drug
Intervention Name(s)
Long GnRH agonist + HRT
Intervention Description
Intervention group:(Long GnRH agonist + HRT) From day 18-21 of the previous cycle, 0.5 cc of Superfect is injected daily and vaginal ultrasound is performed 10-14 days later If the endometrial thickness is less than 5 mm and there are no ovarian cysts, estradiol is started like HRT treatment and the agonist dose of GnRH starts with estradiol. It is halved (0.25 cc superfect) and superfect is prescribed until progesterone is started. At the time of progesterone administration, the administration of superfect is discontinued. Injections of estradiol and progesterone is the same as for the HRT group
Intervention Type
Drug
Intervention Name(s)
HRT
Intervention Description
In the HRT group, from the second day of the cycle, the participant receives 2 mg of estradiol daily and this drug is increased to 6 mg per day in three days.Ten days later, they undergo vaginal ultrasound to check the thickness of the endometrium. If the thickness of the endometrium is greater than 8 mm, inject able progesterone is prescribed and the patient is a candidate for FET transfer. If the thickness is less than 7 mm, it is necessary to increase the dose of estradiol and continue treatment with it. The patient undergoes vaginal ultrasound every three days and if the desired thickness does not reach 21 days after the start of the cycle, the cycle is canceled
Primary Outcome Measure Information:
Title
Endometrial thickness
Description
Endometrial thickness on the day of transfer will be measured by transvaginal ultrasound
Time Frame
On the day of transfer
Title
Chemical pregnancy
Description
A positive beta hCG levels
Time Frame
14 days after transfer
Title
Clinical pregnancy
Description
The gestational sac will be observed by Ultrasonography
Time Frame
12 weeks of pregnancy
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The first or second cycle of embryo transfer Normal uterine cavity PCO diagnosis based on Rotterdam criteria and correction (2018) Age 20 to 40 years
Exclusion Criteria:
Infertility with severe male factor endometriosis immunological disease FSH higher than 10 BMI greater than or equal to 30 Endometrial thickness on the day of transfer is less than 7 mm History of recurrent miscarriage
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashraf Moini, professor
Organizational Affiliation
Tehran University of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arash women's hospital,Tehran university of medical sciences
City
Tehran
ZIP/Postal Code
1653915981
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
It is not yet known if there will be a plan to make this available
Learn more about this trial
GnRH Agonist Plus Hormone Replacement Therapy vs Hormone Replacement Therapy on IVF Outcomes
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