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

Shanghai First Maternity and Infant Hospital

Status: Not yet enrolling

Conditions: Infertility

Treatments: Procedure: duostim vs. two antagonist ovarian stimulations

Study type: Interventional

Funder types: Other

Identifiers

NCT06093984

shanghaiFMIH-20231006

Details and patient eligibility

About

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

Full 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.

Enrollment: 260 estimated patients

Sex: Female

Ages: 20 to 44 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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260 participants in 2 patient groups

Dual Stimulation Protocol

Experimental group

Description:

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

Treatment:

Procedure: duostim vs. two antagonist ovarian stimulations

Antagonist Stimulation Protocol

Active Comparator group

Description:

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

Treatment:

Procedure: duostim vs. two antagonist ovarian stimulations