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

Sponsor
Reproductive & Genetic Hospital of CITIC-Xiangya (Other)
Overall Status
Completed
CT.gov ID
NCT03578172
Collaborator
(none)
186
1
2
16.1
11.6

Study Details

Study Description

Brief Summary

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).

Condition or Disease Intervention/Treatment Phase
  • Drug: human menopausal gonadotrophin
  • Drug: hormone replacement therapy
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
186 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official 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
Actual Study Start Date :
Jul 18, 2018
Actual Primary Completion Date :
Oct 20, 2019
Actual Study Completion Date :
Nov 20, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Experimental-HMG stimulation group

Women will be subjected to ovarian stimulation for endometrial preparation using human menopausal gonadotrophin before blastocyst transfer

Drug: human menopausal gonadotrophin
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.

Active Comparator: Control-HRT group

Women will be subjected to hormone replacement therapy for endometrial preparation before blastocyst transfer

Drug: hormone replacement therapy
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.

Outcome Measures

Primary Outcome Measures

  1. Ongoing pregnancy rate [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 Outcome Measures

  1. Cycle cancellation rate [the day of embryo transfer]

  2. Implantation rate [4th weeks after embryo transfer]

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

  3. Clinical pregnancy rate [4th weeks after embryo transfer]

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

  4. Early miscarriage rate [12th weeks gestational age]

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

  5. Biochemical pregnancy rate [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 35 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Reproductive & Genetic Hospital of CITIC-XIANGYA Changsha Hunan China 410000

Sponsors and Collaborators

  • Reproductive & Genetic Hospital of CITIC-Xiangya

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Reproductive & Genetic Hospital of CITIC-Xiangya
ClinicalTrials.gov Identifier:
NCT03578172
Other Study ID Numbers:
  • KYXM-2018001
First Posted:
Jul 6, 2018
Last Update Posted:
Jan 11, 2022
Last Verified:
Jan 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 11, 2022