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

Not Applicable

Not yet recruiting

• Conditions: Infertility
• Interventions: Procedure: Antagonist Stimulation Protocol; Procedure: Double Stimulation Protocol

• Registration Number: NCT05765968
• Lead Sponsor: Shandong University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2023-02-28
• Status Verified: 2023-03
• Study First Submitted QC: 2023-03-09
• Last Update Submitted: 2023-03-12
• Study First Posted: 2023-03-13
• Study Start: 2023-03-14
• Last Update Posted: 2023-03-14
• Primary Completion: 2026-03-01
• Study Completion: 2026-04-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 1198

Inclusion Criteria

1. Women diagnosed with Poseidon criteria or expected poor ovarian responder （the number of oocyte retrieval ≤9）
2. Women aged ≥20 years old
3. Women who are undergoing their first or second ART cycles
4. Women who are undergoing IVF,ICSI or PGT-A cycles
5. 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

1. Women with RIF or RSA
2. Women diagnosed with uterine abnormalities including uterine malformations, adenomyosis, submucosal fibroids, uterine adhesions or endometrial polyps
3. Women with untreated hydrosalpinx that is visible under pelvic ultrasound
4. Women with chromosomal abnormalities, or women who are undergoning PGT-SR or PGT-M cycles
5. Women with a history of canceled FET cycle(s) due to a thin endometrium (<7mm)
6. Man with operation to get sperm

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Antagonist Stimulation Protocol	Antagonist Stimulation Protocol	The classical antagonist protocol were performed by rFSH,hmg and antagonist.
Double Stimulation Protocol	Double Stimulation Protocol	Double stimulations were performed during the follicular and luteal phases in the same cycle by rFSH\&hmg.

Primary Outcome Measures

Name	Time	Method
Cumulative live birth rate	36 months	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.

Secondary Outcome Measures

Name	Time	Method
Number of retrieved oocytes	24 months

Trial Locations

Locations (1)

Shandong University; 🇨🇳 Jinan, Shandong, China