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

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06093984
• Other study ID #: shanghaiFMIH-20231006
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: October 30, 2026

Study information

• Verified date: October 2023
• Source: Shanghai First Maternity and Infant Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 260
• Est. completion date: October 30, 2026
• Est. primary completion date: October 30, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 44 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai First Maternity and Infant Hospital

Outcome

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