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

NCT ID: NCT05765968

Last Updated: 2023-03-14

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

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

1198 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-14

Study Completion Date

2026-04-01

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.

Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Double Stimulation Protocol

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

Group Type EXPERIMENTAL

Double Stimulation Protocol

Intervention Type PROCEDURE

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

Antagonist Stimulation Protocol

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

Group Type ACTIVE_COMPARATOR

Antagonist Stimulation Protocol

Intervention Type PROCEDURE

cummulative live birth outcome within no more than two cycles of in virto fertilization using classical antagonist protocol

Interventions

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Double Stimulation Protocol

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

Intervention Type PROCEDURE

Antagonist Stimulation Protocol

cummulative live birth outcome within no more than two cycles of in virto fertilization using classical antagonist protocol

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Hunan Provincial Maternal and Child Health Care Hospital

OTHER

Sponsor Role collaborator

Jinghua Hospital of Shenyang

UNKNOWN

Sponsor Role collaborator

Xinjiang Jiayin Hospital

UNKNOWN

Sponsor Role collaborator

The Affiliated Hospital of Inner Mongolia Medical University

OTHER

Sponsor Role collaborator

Guangdong Second Provincial General Hospital

OTHER

Sponsor Role collaborator

The Affiliated Hospital of Qingdao University

OTHER

Sponsor Role collaborator

Wuhan Tongji Reproductive Medicine Hospital

UNKNOWN

Sponsor Role collaborator

Reproductive & Genetic Hospital of CITIC-Xiangya

OTHER

Sponsor Role collaborator

Shandong University

OTHER

Sponsor Role lead

Responsible Party

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Chen Zi-Jiang

Academician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Shandong University

Jinan, Shandong, China

Site Status

Countries

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China

Other Identifiers

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DouAnt

Identifier Type: -

Identifier Source: org_study_id

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