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

Not Applicable
Not yet recruiting
Conditions
Infertility
Interventions
Procedure: duostim vs. two antagonist ovarian stimulations
Registration Number
NCT06093984
Lead Sponsor
Shanghai First Maternity and Infant Hospital
Brief Summary

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

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.

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
Female
Target Recruitment
260
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
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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
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Dual Stimulation Protocolduostim vs. two antagonist ovarian stimulationsDual stimulations were performed during the follicular and luteal phases in the same cycle.
Antagonist Stimulation Protocolduostim vs. two antagonist ovarian stimulationsAntagonist stimulations were performed during two consecutive follicular phases in two cycles.
Primary Outcome Measures
NameTimeMethod
Cumulative live birth rate36 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
NameTimeMethod
Total amount of Gn used during ovarian stimulation24 months

Total amount of Gn used during ovarian stimulation

Number of retrieved oocytes24 months

Number of retrieved oocytes after ovarian stimulation.

Clinical pregnancy rate36 months

Twenty days after conception, transvaginal ultrasonography will be performed. Clinical pregnancy will be diagnosed with detection of an intrauterine gestational sac.

Time to live birth (TTLB)36 months

The TTLB was measured as the time from ovarian stimulation to a live birth.

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