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

Infertility, Female Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03578172
• Other study ID #: KYXM-2018001
• Status: Completed
• Phase: N/A
• Start date: July 18, 2018
• Est. completion date: November 20, 2019

Study information

• Verified date: January 2022
• Source: Reproductive & Genetic Hospital of CITIC-Xiangya
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 186
• Est. completion date: November 20, 2019
• Est. primary completion date: October 20, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility
• Infertility, Female
• Intrauterine Adhesion
• Tissue Adhesions

Intervention

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.
• hormone replacement therapy
Women will be given 17 ß-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.

Locations

Country	Name	City	State
China	Reproductive & Genetic Hospital of CITIC-XIANGYA	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Reproductive & Genetic Hospital of CITIC-Xiangya

Country where clinical trial is conducted

China, 

Outcome

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