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Completed

NCT Number: NCT03300518

Effectiveness of Estradiol Valerate Pretreatment in Antagonist Protocol for Poor Ovarian Response Patient

The purpose of study is to assess the efficacy of add-on estrogen pretreatment in GnRH antagonist protocol on oocyte retrieval as compared with GnRH antagonist protocol for patients with poor ovarian response Add-on estrogen pretreatment protocol is superior to none pretreatment GnRH antagonist protocol for the number of oocytes retrieval

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

40 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Reproductive & Genetic Hospital of Citic-Xiangya

Changsha, Hunan, China

About this study

Women of advanced maternal age seeking ART treatment are characterized as poor ovarian responders in the process of ovarian simulation. Poor response to ovarian stimulation causes high cycle cancellation rate and extremely low pregnancy rate.

More attention has been paid to the potential interest of steroid pretreatments in GnRH antagonist cycles; not only for scheduling the GnRH antagonist cycles, but also for synchronizing the follicular growth which may result in more oocytes retrieved. But available clinical results are controversial.

Previous studies have shown that utilizing the natural negative feedback of the hypothalamus-pituitary-ovary axis induced by estradiol valerate pretreatment effectively prevented inter-cycle increases in follicle-stimulating hormone, improved follicle synchronization, and resulted in a more coordinated follicular development, leading to the recovery of more mature oocytes. However none of the randomized controlled studies compared estradiol valerate pretreatment or not on treatment outcomes, ongoing pregnancy rate, directly on poor response patients using estradiol valerate pretreatment in GnRH antagonist protocol.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Bologna criteria

  • At least two of the following three features must be present:
  • Advanced maternal age (≥40 years) or any other risk factor for POR
  • A previous POR (≤3 oocytes with a conventional stimulation protocol)
  • An abnormal ovarian reserve test (i.e. antral follicle count < 5-7 follicles or AMH< 0.5 - 1.1 ng/mL)

Exclusion criteria

  • Age ≥45 years,
  • Patients who conducted PGD/PGS, and donor egg cycles were excluded.
  • Presence of unilateral ovary absence
  • Abnormal uterine deformity or structure.
  • Spontaneous abortion patients with three or more (including biochemical pregnancy abortion)
  • With other endocrine disease, ovulation disorders such as adrenal cortex function or thyroid dysfunction
  • Have assisted reproductive technology contraindications or pregnancy contraindication of patients

Treatment and study plan

Follitropin Beta;MSD

Drug

Patients will start stimulation with a daily s.c. injection of follitropin beta( 300IU Puregonon;MSD) menstrual cycle day 2 or 3.

Other names: Puregon

Ganirelix

Drug

A daily administration of ganirelix (0.25 mg Orgalutran; MSD) was introduced when the leading follicle is near 13mm, and was repeated up to the time of hCG administration.

Other names: Orgalutran

HCG

Drug

Ovulation was triggered when the leading follicles reach 18-20mm and at least two follicles 17-18mm , HCG 10000 IU is used to trigger

Other names: Ovidrel

estradiol valerate

Drug

Estradiol valerate (progynova,Schering) daily dose of 4 mg (2 mg twice a day) was given orally, started 7 days before the presumed onset of menses and administered up to 2 days of the next menstrual cycle

Other names: progynova

Primary outcomes

  1. The number of oocytes retrieved by the IVG 36 hours after hCG administration

    Time frame: 36 hours after hCG administration

    The total MII oocytes retrievedd

Secondary outcomes

  1. Clinical pregnancy rate

    Time frame: 6weeks

    clinical pregnancy, defined as intrauterine pregnancy with a positive heartbeat at 6 weeks of gestation.Clinical pregnancy rate:Number of clinical pregnancies expressed per 100 initiated cycles, aspiration cycles, or embryo transfer cycles. When clinical pregnancy rates are given, the denominator must be specified.

  2. ongoing pregnancy rate

    Time frame: 12weeks

    ongoing pregnancy defined as an intact pregnancy at 12 weeks of gestation

  3. Optimal number of embryo

    Time frame: 1 week

    According to the embryonic developmental rate and morphology, the high quality embryos were defined as the next day (D2) transplanted embryos reached 3 or 4 cells and the third day (D3) transplanted embryos reached 6 to 8 cells with morphological grade 1 or 2

Sponsors and collaborators

Lead sponsor

Reproductive & Genetic Hospital of CITIC-Xiangya

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study title

A Randomized Study to Analysis the Effectiveness of Estradiol Valerate Pretreatment in Antagonist Protocol for Poor Ovarian Response Patient

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Oct 3, 2017
Registry last updated
Jan 11, 2022

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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