Comparison of 3 Different Protocols for Preventing Premature Ovulation in Ovarian Stimulation Cycles

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

297 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-15

Study Completion Date

2024-09-30

Brief Summary

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The aim of study is to evaluate the results of three different protocols for prevention of premature ovulation in ovarian stimulation cycles. All patients that undergo IVF cycles are randomly divided into three groups. The first group is cetrorelix, the second group is medroxyprogesterone acetate and the third group is dydrogesterone.

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Detailed Description

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Approximately %10-15 of couples of reproductive age have infertility issues. Ovulation induction and in vitro fertilization (IVF) are the main treatments for infertility. With ovarian stimulation (OS), the efficiency of IVF has been increased by collecting more than one oocytes and thus providing more embryos. Multifollicular growth in OS may cause an increase in sex steroids and an early LH peak, thus premature ovulation. Pituitary suppression with certain drugs has been used to prevent premature ovulation.. Among these drugs, it has been observed that GnRH agonists can cause down-regulation, hypo-estrogenic symptoms, ovarian cyst formation and Ovarian Hyperstimulation Syndrome (OHSS), while antagonists may have side effects such as low oocyte count and high cycle cancellation. The use of progesterone preparations as an alternative to these drugs recently gained ground.

Data including age, BMI, the duration of infertility, the type of infertility, antral follicle count, serum day 3 FSH level, Serum anti-Müllerian hormone level, total gonadotropin dose, stimulation time, pituitary suppression starting day, duration of pituitary suppression, premature ovulation, number of total oocyte count, the number of total M2, the number of PN , the number of Day 5 blast, number of transferred embryos, endometrial thickness on the day of transfer will be recorded. When the follicle size reaches 13-14 mm, patients will be randomized into 3 groups. Group 1 (Cetrorelix: n=99, 0.25 mg/day subcutaneously), Group 2 (Medroxyprogesterone Acetate: n=99, 2x5mg/day orally) and Group 3 (Dydrogesterone: n=99, 3x10 mg/day orally). Human chorionic gonadotropin (hCG) will be used for trigger when at least 2 follicles' diameter reaches 17-18mm for ovulation. Thirty-six hours after the hCG injection, the patient's oocytes will be collected. During 2-5 days of embryo culture, embryo quality will be determined according to D.Gardner criteria (1999). Embryos will be frozen as blast on the 5th day and transferred to the frozen cycle to be planned within the next month. Clinical pregnancy rates will be recorded by performing a blood test for on the 12th day after the procedure.

The aim of this study is to evaluate the results of three different protocols for prevention of premature ovulation in ovarian stimulation cycles. All patients undergo IVF cycles are randomly divided in to three groups. The first group is cetrorelix, the second group is medroxyprogesterone acetate and the third group is dydrogesterone.

Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Gonadotropin-releasing hormone (GnRH) antagonist

Cetrotide® (0.25 mg, MerckSerono Pharmaceuticals, Darmstadt, Germany)

Group Type EXPERIMENTAL

Gonadotropin releasing hormone antagonist (Cetrotide)

Intervention Type DRUG

clinical pregnancy rates

Medroxyprogesterone acetate

Tarlusal® (5 mg, Deva Pharma, Istanbul, Turkey)

Group Type EXPERIMENTAL

Medroxyprogesterone Acetate (Tarlusal)

Intervention Type DRUG

clinical pregnancy rates

Dydrogesterone

Duphaston® (10mg, Abbott Laboratories, Chicago, Illinois, ABD)

Group Type EXPERIMENTAL

Dydrogesterone

Intervention Type DRUG

clinical pregnancy rates

Interventions

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Gonadotropin releasing hormone antagonist (Cetrotide)

clinical pregnancy rates

Intervention Type DRUG

Medroxyprogesterone Acetate (Tarlusal)

clinical pregnancy rates

Intervention Type DRUG

Dydrogesterone

clinical pregnancy rates

Intervention Type DRUG

Other Intervention Names

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Cetrotide Tarlusal Duphaston (Duphaston)

Eligibility Criteria

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Inclusion Criteria

* Women aged 20-38 years who applied to the infertility clinic
* BMI\<25 kg/m2
* AMH\>1 ng/mL

Exclusion Criteria

* Adenomyosis
* Endometriosis
* Untreated uterine pathology
* Hormonal therapy in the last 3 months
* Contraindication for ovulation stimulation
* BMI\>25 kg/m2
* AMH\<1 ng/mL

Minimum Eligible Age

20 Years

Maximum Eligible Age

38 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes