NCT05765968

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,198

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 28, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 13, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

March 14, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

March 14, 2023

Status Verified

March 1, 2023

Enrollment Period

3 years

First QC Date

February 28, 2023

Last Update Submit

March 12, 2023

Conditions

Infertility

Keywords

Poseidon criteriaDouble stimulationCummulative live birth

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Number of retrieved oocytes

    24 months

Other Outcomes (6)

  • Clinical pregnancy rate

    36 months

  • Incidence of obstetric complications

    36 months

  • Incidence of perinatal complications

    36 months

  • +3 more other outcomes

Study Arms (2)

Double Stimulation Protocol

EXPERIMENTAL

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

Procedure: Double Stimulation Protocol

Antagonist Stimulation Protocol

ACTIVE COMPARATOR

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

Procedure: Antagonist Stimulation Protocol

Interventions

Double Stimulation ProtocolPROCEDURE

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

Double Stimulation Protocol
Antagonist Stimulation ProtocolPROCEDURE

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

Antagonist Stimulation Protocol

Eligibility Criteria

Age20 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shandong University

Jinan, Shandong, China

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Academician

Study Record Dates

First Submitted

February 28, 2023

First Posted

March 13, 2023

Study Start

March 14, 2023

Primary Completion

March 1, 2026

Study Completion

April 1, 2026

Last Updated

March 14, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)