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

Shandong University

Status: Not yet enrolling

Conditions: Infertility

Treatments: Procedure: Antagonist Stimulation Protocol; Procedure: Double Stimulation Protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT05765968

DouAnt

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,198 estimated patients

Sex: Female

Ages: 20+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,198 participants in 2 patient groups

Double Stimulation Protocol

Experimental group

Description:

Double stimulations were performed during the follicular and luteal phases in the same cycle by rFSH\&hmg.

Treatment:

Procedure: Double Stimulation Protocol

Antagonist Stimulation Protocol

Active Comparator group

Description:

The classical antagonist protocol were performed by rFSH,hmg and antagonist.

Treatment:

Procedure: Antagonist Stimulation Protocol