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

Not Applicable
Completed
Conditions
Infertility, Female
Intrauterine Adhesion
Interventions
Drug: human menopausal gonadotrophin
Drug: hormone replacement therapy
Registration Number
NCT03578172
Lead Sponsor
Reproductive & Genetic Hospital of CITIC-Xiangya
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).

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
186
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
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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
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Experimental-HMG stimulation grouphuman menopausal gonadotrophinWomen will be subjected to ovarian stimulation for endometrial preparation using human menopausal gonadotrophin before blastocyst transfer
Control-HRT grouphormone replacement therapyWomen will be subjected to hormone replacement therapy for endometrial preparation before blastocyst transfer
Primary Outcome Measures
NameTimeMethod
Ongoing pregnancy rate10th 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
NameTimeMethod
Cycle cancellation ratethe day of embryo transfer
Implantation rate4th weeks after embryo transfer

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

Clinical pregnancy rate4th weeks after embryo transfer

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

Biochemical pregnancy rate4th 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

Early miscarriage rate12th weeks gestational age

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

Trial Locations

Locations (1)

Reproductive & Genetic Hospital of CITIC-XIANGYA

🇨🇳

Changsha, Hunan, China

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