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

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

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).

Study Overview

• Status: Completed
• Conditions: Infertility, Female; Intrauterine Adhesion
• Intervention / Treatment: Drug: human menopausal gonadotrophin; Drug: hormone replacement therapy

• Study Type: Interventional
• Enrollment (Actual): 186
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410000
      • Reproductive & Genetic hospital Of CITIC-Xiangya

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 35 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cycle cancellation rate		the day of embryo transfer
Implantation rate	Sacs seen in early ultrasound divided by the number of embryos transferred	4th weeks after embryo transfer
Clinical pregnancy rate	Number of patients with ultrasound evidence of pregnancy divided by the number of embryo transfers	4th weeks after embryo transfer
Early miscarriage rate	Number of losses of clinical pregnancies divided by number of clinical pregnancies	12th weeks gestational age
Biochemical pregnancy rate	number of pregnancies with a transient elevation of serum human chorionic gonadotropin(β-hCG) level (>10 mIU/ml) divided by number of embryo transfers	4th weeks after embryo transfer

Collaborators and Investigators

• Sponsor: Reproductive & Genetic Hospital of CITIC-Xiangya

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 18, 2018
• Primary Completion (ACTUAL): October 20, 2019
• Study Completion (ACTUAL): November 20, 2019

Study Registration Dates

• First Submitted: June 24, 2018
• First Submitted That Met QC Criteria: June 24, 2018
• First Posted (ACTUAL): July 6, 2018

Study Record Updates

• Last Update Posted (ACTUAL): January 11, 2022
• Last Update Submitted That Met QC Criteria: January 9, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis; Cicatrix; Infertility; Tissue Adhesions; Infertility, Female; Physiological Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists; Reproductive Control Agents; Fertility Agents, Female; Fertility Agents; Hormones; Menotropins
• Other Study ID Numbers: KYXM-2018001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No