HRT Versus MOS for Endometrial Preparation Prior to FET in Non PCOS Patients
Primary Purpose
Infertility
Status
Unknown status
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Estradiol valerate
Sequential Clomiphene citrate and Gonadotropin
Sponsored by
About this trial
This is an interventional treatment trial for Infertility focused on measuring Frozen-thawed embryo transfer, FET protocols
Eligibility Criteria
Inclusion Criteria:
- Women without PCOS as defined by the Rotterdam criteria.
- Presence of at least 2 cryopreserved good quality cleavage-stage embryo (good quality cleavage-stage embryos display stage-specific cell division, have blastomeres of fairly equal size with few to no cytoplasmic fragments).
Exclusion Criteria:
- PCOS or polycystic ovary on ultrasound scan.
- Moderate or severe endometriosis.
- Hydrosalpinx.
- Uterine abnormalities or myoma.
- Previous uterine surgery.
Sites / Locations
- Fertility Care Unit (FCU) in Mansoura University HospitalRecruiting
- Private fertility care centersRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
HRT group
MOS group
Arm Description
Women will be subjected to HRT using Estradiol valerate before FET
Women will be subjected to MOS using sequential clomiphene citrate and gonadotropin before FET
Outcomes
Primary Outcome Measures
Clinical pregnancy rate
Number of clinical pregnancies (defined as presence of at least one intrauterine gestational sac with fetal pole and cardiac activity on TVS scan at 4-6 weeks after the ET) divided by the number of ET procedures
Secondary Outcome Measures
Implantation rate
Number of gestational sacs on TVS scan at 4-6 weeks after ET divided by the number of transferred embryos
Miscarriage rate
Number of first trimester miscarriages (before 12 weeks gestational age) divided by the number of clinical pregnancies
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02330757
Brief Title
HRT Versus MOS for Endometrial Preparation Prior to FET in Non PCOS Patients
Official Title
Hormone Replacement Therapy Versus Minimal Ovarian Stimulation for Endometrial Preparation Prior to Frozen-thawed Embryo Transfer in Non Polycystic Ovarian Syndrome Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
January 2021 (Anticipated)
Study Completion Date
March 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Evaluation of endometrial preparation using either hormonal therapy or ovarian stimulation prior to frozen-thawed embryo transfer (FET) in patients without polycystic ovarian syndrome (PCOS)
Detailed Description
Women will be randomly divided into two groups; one will be subjected to endometrial preparation by hormone replacement therapy (HRT) and the other will be subjected to minimal ovarian stimulation (MOS). Women in the HRT group will be given estradiol valerate 4 mg daily from day 2 to day 12 of the cycle then the endometrial thickness will be assessed on day 13 by transvaginal sonography (TVS). If the endometrium is ≥ 8 mm and of moderate echogenicity, luteal phase support (using progesterone supplements) will be started but if the endometrium is < 8 mm, estradiol valerate will be continued until reaching appropriate endometrial thickness and echogenicity then the luteal phase support will be started. Women in the MOS group will be given clomiphene citrate in dose of 100-150 mg daily for 5 days (from day 2 to day 6 of the cycle) then switched to low dose gonadotropin (75-150 IU daily) followed by monitoring of the follicular growth (folliculometry) ); starting from day 10 of the stimulation cycle and repeated every 2 days. Final oocyte maturation will be induced by administration of human chorionic gonadotropin (HCG) when there will be at least one leading follicle > 18 mm in diameter followed by luteal phase support (using progesterone supplements) after 48 hours. In both groups, FET will be planned in the appropriate day according to the stage that the embryos have been cryopreserved in it.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
Frozen-thawed embryo transfer, FET protocols
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HRT group
Arm Type
Active Comparator
Arm Description
Women will be subjected to HRT using Estradiol valerate before FET
Arm Title
MOS group
Arm Type
Active Comparator
Arm Description
Women will be subjected to MOS using sequential clomiphene citrate and gonadotropin before FET
Intervention Type
Drug
Intervention Name(s)
Estradiol valerate
Other Intervention Name(s)
Cycloprogynova (white tablets)
Intervention Description
Women will be given estradiol valerate 4 mg daily from day 2 to day 12 of the cycle then the endometrial thickness will be assessed on day 13 by transvaginal sonography (TVS). If the endometrium is ≥ 8 mm and of moderate echogenicity, luteal phase support (using progesterone supplements) will be started but if the endometrium is < 8 mm, estradiol valerate will be continued until reaching appropriate endometrial thickness and echogenicity then the luteal phase support will be started.
Intervention Type
Drug
Intervention Name(s)
Sequential Clomiphene citrate and Gonadotropin
Other Intervention Name(s)
Sequential Clomid and Menogon
Intervention Description
Women will be given clomiphene citrate in dose of 100-150 mg daily for 5 days (from day 2 to day 6 of the cycle) then switched to low dose gonadotropin (75-150 IU daily) followed by monitoring of the follicular growth (folliculometry) ); starting from day 10 of the stimulation cycle and repeated every 2 days. Final oocyte maturation will be induced by administration of human chorionic gonadotropin (HCG) when there will be at least one leading follicle > 18 mm in diameter followed by luteal phase support (using progesterone supplements) after 48 hours.
Primary Outcome Measure Information:
Title
Clinical pregnancy rate
Description
Number of clinical pregnancies (defined as presence of at least one intrauterine gestational sac with fetal pole and cardiac activity on TVS scan at 4-6 weeks after the ET) divided by the number of ET procedures
Time Frame
6 weeks after embryo transfer
Secondary Outcome Measure Information:
Title
Implantation rate
Description
Number of gestational sacs on TVS scan at 4-6 weeks after ET divided by the number of transferred embryos
Time Frame
6 weeks after embryo transfer
Title
Miscarriage rate
Description
Number of first trimester miscarriages (before 12 weeks gestational age) divided by the number of clinical pregnancies
Time Frame
12 weeks gestational age
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women without PCOS as defined by the Rotterdam criteria.
Presence of at least 2 cryopreserved good quality cleavage-stage embryo (good quality cleavage-stage embryos display stage-specific cell division, have blastomeres of fairly equal size with few to no cytoplasmic fragments).
Exclusion Criteria:
PCOS or polycystic ovary on ultrasound scan.
Moderate or severe endometriosis.
Hydrosalpinx.
Uterine abnormalities or myoma.
Previous uterine surgery.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed S Abdelhafez, Dr
Phone
+201144523366
Email
msabdelhafez@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed S Abdelhafez, Dr
Organizational Affiliation
Mansoura University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fertility Care Unit (FCU) in Mansoura University Hospital
City
Mansourah
State/Province
Dakahlia
ZIP/Postal Code
35111
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed S Abdelhafez, Dr
Phone
+201144523366
Email
msabdelhafez@gmail.com
Facility Name
Private fertility care centers
City
Mansourah
State/Province
Dakahlia
Country
Egypt
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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HRT Versus MOS for Endometrial Preparation Prior to FET in Non PCOS Patients
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