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Completed

NCT Number: NCT03578172

HMG Stimulation Versus HRT for Endometrial Preparation Prior to Blastocyst Transfer in Moderate to Severe IUA Patients

Evaluation of endometrial preparation using either human menopausal gonadotrophin (HMG) stimulation and hormone replacement therapy (HRT) prior to blastocyst transfer in patients with moderate to severe intrauterine adhesion (IUA).

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Key information

Conditions

Infertility, Female Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gynatresia Infertility Intrauterine Adhesion Urogenital Diseases

Age range

20 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Reproductive & Genetic Hospital of CITIC-XIANGYA

Changsha, Hunan, 410000, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • BMI 18~23 kg/m2
  • Women with moderate to severe IUA as defined by the American Fertility Society classification (1988)
  • Presence of at least 3 cryopreserved cleavage-stage embryos (including 1 good quality) or blastocysts

Exclusion criteria

  • Using embryos from donor oocytes
  • Preimplantation genetic diagnosis(PGD)/Preimplantation genetic screening(PGS) cycles
  • Moderate or severe endometriosis
  • Untreated unilateral or bilateral hydrosalpinx
  • Uterine adenomyosis, uterine myoma (submucous,intramural myoma >4 cm),>1cm septate uterus, double uterus, bicornuate uterus, unicornuate uterus

Treatment and study plan

human menopausal gonadotrophin

Drug

experimental group:Women will be given HMG 37.5-150IU daily followed by monitoring of the follicular growth (folliculometry) when serum Estradiol (E2)<100pg/ml，progesterone (P)<1ng/ml. Final oocyte maturation will be induced by administration of human chorionic gonadotropin (HCG) when there will be at least one leading follicle ≥20mm in diameter followed by luteal phase support (using progesterone supplements) after 24 hours.

hormone replacement therapy

Drug

Women will be given 17 β-estradiol hemihydrate 2 mg and estrogen gel 5 g daily from day 3 of the cycle then the endometrial thickness will be assessed on day 7 by transvaginal sonography (TVS). If the endometrium is ≥ 9 mm, luteal phase support (using progesterone supplements) will be started but if the endometrium is < 9 mm, estradiol will be continued until reaching appropriate endometrial thickness and then the luteal phase support will be started. The cycle will be cancelled If the estradiol administration >60 days.

Primary outcomes

  1. Ongoing pregnancy rate

    Time frame: 10th week after embryo transfer

    Ongoing pregnancy is defined as the presence of a gestational sac with foetal heartbeat by transvaginal ultrasound at 10th week after embryo transfer（ET）

Secondary outcomes

  1. Cycle cancellation rate

    Time frame: the day of embryo transfer

  2. Implantation rate

    Time frame: 4th weeks after embryo transfer

    Sacs seen in early ultrasound divided by the number of embryos transferred

  3. Clinical pregnancy rate

    Time frame: 4th weeks after embryo transfer

    Number of patients with ultrasound evidence of pregnancy divided by the number of embryo transfers

  4. Early miscarriage rate

    Time frame: 12th weeks gestational age

    Number of losses of clinical pregnancies divided by number of clinical pregnancies

  5. Biochemical pregnancy rate

    Time frame: 4th weeks after embryo transfer

    number of pregnancies with a transient elevation of serum human chorionic gonadotropin(β-hCG) level (>10 mIU/ml) divided by number of embryo transfers

Sponsors and collaborators

Lead sponsor

Reproductive & Genetic Hospital of CITIC-Xiangya

Other

Registry information

Official study title

Randomized, Controlled Trial to Assess the Efficacy of Human Menopausal Gonadotrophin Stimulation and Hormone Replacement Therapy for Endometrial Preparation Prior to Blastocyst Transfer in Moderate to Severe Intrauterine Adhesion Patients

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 6, 2018
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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