Cumulative Live Birth After Double Stimulation Protocol Versus Antagonist Protocol for Poor Ovarian Responders

Study Overview
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Brief Summary
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To compare the difference in cumulative live birth rates within one year between double stimulations protocol and two-cycle antagonist protocol in poor ovarian responders.

Detailed Description
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The theory of multicyclic development of follicles during the menstrual cycle prompted new approaches to ovarian stimulation such as double stimulation within the same menstrual cycle, in both follicular and luteal phases. The double ovarian stimulation protocol has been proposed to optimize the number of oocytes retrieved within the shortest possible timeframe.In general, the aim of DUOSTIM is to obtain the highest number of oocytes in the shortest time, thus avoiding waste of time, which is crucial for these patients.

Official Title
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Cumulative Live Birth Rates in the Same Cycle Double Stimulation Protocol Versus a Two-cycle Antagonist Stimulation Protocol in IVF Patients With a Poor Prognosis: a Randomized Clinical Trial

Conditions
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Infertility

Intervention / Treatment
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* Procedure: Double Stimulation Protocol
* Procedure: Antagonist Stimulation Protocol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women diagnosed with Poseidon criteria or expected poor ovarian responder （the number of oocyte retrieval ≤9） Women aged ≥20 years old Women who are undergoing their first or second ART cycles Women who are undergoing IVF,ICSI or PGT-A cycles Women with the number of oocyte retrieval ≤9 after their first ovarian stimulation cycle since radomization, and the number of follicle measuring 8mm or larger ≥3 Exclusion Criteria: Women with RIF or RSA Women diagnosed with uterine abnormalities including uterine malformations, adenomyosis, submucosal fibroids, uterine adhesions or endometrial polyps Women with untreated hydrosalpinx that is visible under pelvic ultrasound Women with chromosomal abnormalities, or women who are undergoning PGT-SR or PGT-M cycles Women with a history of canceled FET cycle(s) due to a thin endometrium (<7mm) Man with operation to get sperm

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Double Stimulation Protocol<br>Double stimulations were performed during the follicular and luteal phases in the same cycle by rFSH&hmg. | Procedure: Double Stimulation Protocol<br>* cummulative live birth outcome after two cycles of in virto fertilization using double stimulation protocol, which refers to two cycles of ovarian stimulation in both follicular phase and luteal phase within the same menstrual cycle<br>|
| Active Comparator: Antagonist Stimulation Protocol<br>The classical antagonist protocol were performed by rFSH,hmg and antagonist. | Procedure: Antagonist Stimulation Protocol<br>* cummulative live birth outcome within no more than two cycles of in virto fertilization using classical antagonist protocol<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative live birth rate | Live birth is defined as the delivery of any viable infant at 28 weeks or more of gestation after our interventions, and cumulative live birth rate is calculated by dividing the number of women achieving live birth after transfers of all study-specific embryos (up to 3 transfers of single blastocycst within 1 year after randomization), by the total number of women randomized to the specific group. | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of retrieved oocytes |  | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Poseidon criteria, Double stimulation, Cummulative live birth