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Trial record 9 of 86 for:    gonadotropin | Recruiting, Not yet recruiting, Available Studies | "Infertility"

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

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ClinicalTrials.gov Identifier: NCT03578172
Recruitment Status : Recruiting
First Posted : July 6, 2018
Last Update Posted : July 19, 2018
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Infertility, Female Intrauterine Adhesion Drug: human menopausal gonadotrophin Drug: hormone replacement therapy Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 172 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 : July 18, 2018
Estimated Primary Completion Date : December 30, 2018
Estimated Study Completion Date : February 28, 2019

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Ongoing pregnancy rate [ Time Frame: 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 [ Time Frame: the day of embryo transfer ]
  2. Implantation rate [ Time Frame: 4th weeks after embryo transfer ]
    Sacs seen in early ultrasound divided by the number of embryos transferred

  3. Clinical pregnancy rate [ Time Frame: 4th weeks after embryo transfer ]
    Number of patients with ultrasound evidence of pregnancy divided by the number of embryo transfers

  4. Early miscarriage rate [ Time Frame: 12th weeks gestational age ]
    Number of losses of clinical pregnancies divided by number of clinical pregnancies

  5. Biochemical pregnancy rate [ Time Frame: 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



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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03578172


Contacts
Contact: hui guo +86-731-82355100 tuwei12@sina.com

Locations
China, Hunan
Reproductive & Genetic Hospital of CITIC-XIANGYA Recruiting
Changsha, Hunan, China, 410000
Contact: Hui Guo, Doctor    +86-731-82355100    tuwei12@sina.com   
Sponsors and Collaborators
Reproductive & Genetic Hospital of CITIC-Xiangya

Responsible Party: Reproductive & Genetic Hospital of CITIC-Xiangya
ClinicalTrials.gov Identifier: NCT03578172     History of Changes
Other Study ID Numbers: KYXM-2018001
First Posted: July 6, 2018    Key Record Dates
Last Update Posted: July 19, 2018
Last Verified: July 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Infertility
Infertility, Female
Tissue Adhesions
Genital Diseases, Male
Genital Diseases, Female
Cicatrix
Fibrosis
Pathologic Processes
Hormones
Menotropins
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents