Cumulative Live Birth Rates in Dual Ovarian Stimulation Versus Two Antagonist Stimulations in Poor Ovarian Responders

Sponsor

Shanghai First Maternity and Infant Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06093984

Collaborator

(none)

260

Enrollment

Arms

35.9

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

To compare the difference in cumulative live birth rates between dual ovarian stimulation and two antagonist stimulations in poor ovarian responders.

Condition or Disease	Intervention/Treatment	Phase
Infertility	Procedure: duostim vs. two antagonist ovarian stimulations	N/A

Detailed Description

Studies have shown the ability to obtain oocytes with equivalent quality from the follicular and the luteal phase, and a higher number of oocytes within one cycle when using dual ovarian stimulation (duostim). This could be particularly relevant for women with poor ovarian responders (POR). Whether the cumulative live birth rates differ after duostim and two antagonist stimulations in POR remains controversial.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

260 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Randomized Clinical Trial Comparing Cumulative Live Birth Rates in Dual Ovarian Stimulation Versus Two Antagonist Stimulations in Poor Ovarian Responders

Anticipated Study Start Date :

Nov 1, 2023

Anticipated Primary Completion Date :

Oct 30, 2025

Anticipated Study Completion Date :

Oct 30, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dual Stimulation Protocol Dual stimulations were performed during the follicular and luteal phases in the same cycle.	Procedure: duostim vs. two antagonist ovarian stimulations Human menopausal gonadotropin (HMG) 300 IU/day with flexible antagonist protocol is used for ovarian stimulation, except in luteal phase stimulation of the duostim group. In the duostim group, all of the embryos are frozen. Fresh transfers are performed in the control group, frozen embryo transfers are performed in both control and duostim groups.
Active Comparator: Antagonist Stimulation Protocol Antagonist stimulations were performed during two consecutive follicular phases in two cycles.	Procedure: duostim vs. two antagonist ovarian stimulations Human menopausal gonadotropin (HMG) 300 IU/day with flexible antagonist protocol is used for ovarian stimulation, except in luteal phase stimulation of the duostim group. In the duostim group, all of the embryos are frozen. Fresh transfers are performed in the control group, frozen embryo transfers are performed in both control and duostim groups.

Arm

Intervention/Treatment

Experimental: Dual Stimulation Protocol

Dual stimulations were performed during the follicular and luteal phases in the same cycle.

Procedure: duostim vs. two antagonist ovarian stimulations

Human menopausal gonadotropin (HMG) 300 IU/day with flexible antagonist protocol is used for ovarian stimulation, except in luteal phase stimulation of the duostim group. In the duostim group, all of the embryos are frozen. Fresh transfers are performed in the control group, frozen embryo transfers are performed in both control and duostim groups.

Active Comparator: Antagonist Stimulation Protocol

Antagonist stimulations were performed during two consecutive follicular phases in two cycles.

Procedure: duostim vs. two antagonist ovarian stimulations

Outcome Measures

Primary Outcome Measures

Cumulative live birth rate [36 months]
Live birth is defined as the delivery of any alive infant after 22 weeks of gestation after our interventions, and cumulative live birth rate is calculated by the total number of women randomized to the specific group.

Secondary Outcome Measures

Time to live birth (TTLB) [36 months]
The TTLB was measured as the time from ovarian stimulation to a live birth.
Total amount of Gn used during ovarian stimulation [24 months]
Total amount of Gn used during ovarian stimulation
Number of retrieved oocytes [24 months]
Number of retrieved oocytes after ovarian stimulation.
Clinical pregnancy rate [36 months]
Twenty days after conception, transvaginal ultrasonography will be performed. Clinical pregnancy will be diagnosed with detection of an intrauterine gestational sac.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 44 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Women with POR were defined with adjusted Bologna criteria, at least two of the three following criteria: advanced maternal age (40 years); 3 oocytes in previous IVF; and antral follicle count (AFC) 5 and/or anti-Mu¨llerian hormone (AMH) 1.1 ng/ml (this criterion was mandatory)
Aged from 20 to 44 years
Body mass index (BMI) from 19 to 32 kg/m2
No more than two previous IVF cycles were recruited

Exclusion Criteria:

Amenorrhoea
Follicle stimulating hormone (FSH) 20 IU/L or AFC 1
Women with a partner with an extremely severe sperm anomaly or sperm donor use

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Shanghai First Maternity and Infant Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Shanghai First Maternity and Infant Hospital

ClinicalTrials.gov Identifier:

NCT06093984

Other Study ID Numbers:

shanghaiFMIH-20231006

First Posted:

Oct 23, 2023

Last Update Posted:

Oct 23, 2023

Last Verified:

Oct 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Infertility

Study Results

No Results Posted as of Oct 23, 2023