NCT03578172

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
186

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 24, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 6, 2018

Completed
12 days until next milestone

Study Start

First participant enrolled

July 18, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2019

Completed
Last Updated

January 11, 2022

Status Verified

January 1, 2022

Enrollment Period

1.3 years

First QC Date

June 24, 2018

Last Update Submit

January 9, 2022

Conditions

Infertility, FemaleIntrauterine Adhesion

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Cycle cancellation rate

    the day of embryo transfer

  • Implantation rate

    4th weeks after embryo transfer

  • Clinical pregnancy rate

    4th weeks after embryo transfer

  • Early miscarriage rate

    12th weeks gestational age

  • Biochemical pregnancy rate

    4th weeks after embryo transfer

Study Arms (2)

Experimental-HMG stimulation group

EXPERIMENTAL

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

Drug: human menopausal gonadotrophin

Control-HRT group

ACTIVE COMPARATOR

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

Drug: hormone replacement therapy

Interventions

human menopausal gonadotrophinDRUG

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.

Experimental-HMG stimulation group
hormone replacement therapyDRUG

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.

Control-HRT group

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Reproductive & Genetic Hospital of CITIC-XIANGYA

Changsha, Hunan, 410000, China

Location

MeSH Terms

Conditions

Infertility, FemaleGynatresia

Interventions

MenotropinsHormone Replacement Therapy

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesInfertility

Intervention Hierarchy (Ancestors)

Gonadotropins, PituitaryGonadotropinsPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPituitary Hormones, AnteriorPituitary HormonesPeptidesAmino Acids, Peptides, and ProteinsBiological ProductsComplex MixturesDrug TherapyTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2018

First Posted

July 6, 2018

Study Start

July 18, 2018

Primary Completion

October 20, 2019

Study Completion

November 20, 2019

Last Updated

January 11, 2022

Record last verified: 2022-01

Locations

CN(1)