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NCT Number: NCT06093984

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

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

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

20 year–44 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

duostim vs. two antagonist ovarian stimulations

Procedure

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 outcomes

  1. Cumulative live birth rate

    Time frame: 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 outcomes

  1. Time to live birth (TTLB)

    Time frame: 36 months

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

  2. Total amount of Gn used during ovarian stimulation

    Time frame: 24 months

    Total amount of Gn used during ovarian stimulation

  3. Number of retrieved oocytes

    Time frame: 24 months

    Number of retrieved oocytes after ovarian stimulation.

  4. Clinical pregnancy rate

    Time frame: 36 months

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

Sponsors and collaborators

Lead sponsor

Shanghai First Maternity and Infant Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Oct 23, 2023
Registry last updated
Oct 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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