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Not yet recruiting NCT06093984

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

No phase Interventional Infertility

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: duostim vs. two antagonist ovarian stimulations.
Who it may be relevant to
Registry conditions: Infertility. Basic parameters: 20 years — 44 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Cumulative live birth rate [Time frame: 36 months]
Secondary outcome measures (4)
  • Time to live birth (TTLB) [Time frame: 36 months]
  • Total amount of Gn used during ovarian stimulation [Time frame: 24 months]
  • Number of retrieved oocytes [Time frame: 24 months]
  • Clinical pregnancy rate [Time frame: 36 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06093984 · shanghaiFMIH-20231006

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗