Dual FSH/HCG Trigger in Letrozole Stimulated Intrauterine Insemination Cycles in Women With Unexplained Infertility
Primary Purpose
Unexplained Infertility
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Human chorionic gonadotropin
FSH co-trigger
Letrozole
Sponsored by
About this trial
This is an interventional treatment trial for Unexplained Infertility
Eligibility Criteria
Inclusion Criteria:
- Unexplained infertility for more than 2 years
- Normal ovulation proved by midluteal serum progesterone level >5 ng/ml,
- Patent fallopian tubes confirmed by hysterosalpingography or laparoscopy
- Normal semen analysis according to the modified World Health Organization (WHO) criteria
- Normal hormonal profile (FSH, LH, prolactin and TSH) in the early follicular phase.
Exclusion Criteria:
- Other causes of infertility ( tubal factors, polycystic ovary syndrome (PCOS), endometriosis)
- Ovarian cysts,
- FSH >10 mIU/ml.
- Previous intrauterine insemination (IUI )cycles,
- Liver or kidney diseases,
- Hypersensitivity to the used medications.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control
Study
Arm Description
In letrozole stimulated cycle: On the day of ovulation trigger the patient received standard dose of Human chorionic gonadotropin (10,000 IU).
In letrozole stimulated cycle: On the day of ovulation trigger the patient received hCG 10000 IU plus FSH co-trigger (urofollitropin; Fostimon, IBSA, Bazel, Swiz; 75 IU amp) 150 IU injected once .
Outcomes
Primary Outcome Measures
Clinical pregnancy rate per cycle (PR/C) and per woman (PP/W)
Achievement of clinical pregnancy defined as the presence of an intrauterine gestational sac with a pulsating fetal heart beat on ultrasound
Secondary Outcome Measures
Frequency of ovarian hyperstimulation syndrome (OHSS)
Number of participants developed ovarian hyperstimulation syndrome (OHSS) per all women received intervention
Multiple pregnancies
Number of participants had multiple pregnancy per women achieved pregnancy .
The live birth rate per woman (LB/W).
Number of live birth per women receiving intervention.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02739516
Brief Title
Dual FSH/HCG Trigger in Letrozole Stimulated Intrauterine Insemination Cycles in Women With Unexplained Infertility
Official Title
Concomitant Administration of Follicle-stimulating Hormone at the Time of Human Chorionic Gonadotropin Trigger in Letrozole Stimulated Intrauterine Insemination Cycles in Women With Unexplained Infertility
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Benha University
4. Oversight
5. Study Description
Brief Summary
The objective of this study was to evaluate the outcome of follicle stimulating hormone (FSH) co-administration with human chorionic gonadotrophins trigger for women with unexplained infertility (UEI) and assigned for letrozole (LTZ) stimulated intrauterine insemination (IUI) cycles .
Detailed Description
This prospective randomized controlled study included 108 women with unexplained infertility recruited among those attending the Gynecology Outpatient Clinics of, Benha University Hospital, and private settings, Alkalubia, Egypt from Jun 2013 to Aug 2015. The study protocol was approved by the Local Ethics Committee and written informed consents were taken from both partners before starting of the study.
All women received the same regimen of ovarian stimulation using Letrozole (Femara; Novartis pharma AG, Basle, Switzerland) 2.5 mg tab twice daily for 5 days starting from cycle day 3. Transvaginal ultrasound scan (TVS) was performed daily from cycle day 9 and a total of 10,000 IU of hCG (Epifasi, EPICO) was administered to those in whom at least one ovarian follicle was ≥18 mm in size. On the day of hCG administration women were randomly categorized into two groups according to a computer generated random numerical table. Envelopes containing the allocation information were chosen sequentially by patient herself in presence of her husband. Group A received FSH (urofollitropin; Fostimon, IBSA, Bazel, Swiz; 75 IU amp) 150 IU injected once on day of hCG injection and group B received no FSH on day of hCG injection. Intrauterine insemination was performed 36 hours after HCG injection. Women in both groups received luteal phase support in the form of vaginal progesterone, (Prontogest 400 mg Vaginal Pessaries, IBSA) twice a day, starting from the day after IUI and continued till the eighth week, if the pregnancy test was positive.Two weeks later, quantitative ßhCG was estimated to diagnose chemical pregnancy. However, TVS was performed 4 weeks after positive pregnancy test to confirm clinical pregnancy by the presence of gestational sac with fetal echoes and pulsation and to exclude ectopic pregnancy. All women enrolled in the study underwent the study protocol for three consecutive cycles unless got pregnant.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unexplained Infertility
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
108 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Active Comparator
Arm Description
In letrozole stimulated cycle: On the day of ovulation trigger the patient received standard dose of Human chorionic gonadotropin (10,000 IU).
Arm Title
Study
Arm Type
Experimental
Arm Description
In letrozole stimulated cycle: On the day of ovulation trigger the patient received hCG 10000 IU plus FSH co-trigger (urofollitropin; Fostimon, IBSA, Bazel, Swiz; 75 IU amp) 150 IU injected once .
Intervention Type
Drug
Intervention Name(s)
Human chorionic gonadotropin
Intervention Description
In letrozole stimulated cycle; Human chorionic gonadotropin ( hCG) 10000 IU was given intramuscular when the mean ovarian follicle diameter was ≥18 mm.
Intervention Type
Drug
Intervention Name(s)
FSH co-trigger
Intervention Description
In letrozole stimulated cycle; FSH (urofollitropin; Fostimon, IBSA, Bazel, Swiz; 75 IU amp) 150 IU injected once intramuscular when the mean ovarian follicle diameter was ≥18 mm.
Intervention Type
Drug
Intervention Name(s)
Letrozole
Intervention Description
Letrozole oral tablets (Femara 2.5 mg tablet; Novartis Pharma Services, Switzerland) 2.5 mg tab twice daily for 5 days from cycle day 3.
Primary Outcome Measure Information:
Title
Clinical pregnancy rate per cycle (PR/C) and per woman (PP/W)
Description
Achievement of clinical pregnancy defined as the presence of an intrauterine gestational sac with a pulsating fetal heart beat on ultrasound
Time Frame
Throughout the study completion; up to 3 months
Secondary Outcome Measure Information:
Title
Frequency of ovarian hyperstimulation syndrome (OHSS)
Description
Number of participants developed ovarian hyperstimulation syndrome (OHSS) per all women received intervention
Time Frame
Throughout the study completion; up to 3 months
Title
Multiple pregnancies
Description
Number of participants had multiple pregnancy per women achieved pregnancy .
Time Frame
Throughout the study completion; up to 3 months
Title
The live birth rate per woman (LB/W).
Description
Number of live birth per women receiving intervention.
Time Frame
Throughout the study completion; up to 2 year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Unexplained infertility for more than 2 years
Normal ovulation proved by midluteal serum progesterone level >5 ng/ml,
Patent fallopian tubes confirmed by hysterosalpingography or laparoscopy
Normal semen analysis according to the modified World Health Organization (WHO) criteria
Normal hormonal profile (FSH, LH, prolactin and TSH) in the early follicular phase.
Exclusion Criteria:
Other causes of infertility ( tubal factors, polycystic ovary syndrome (PCOS), endometriosis)
Ovarian cysts,
FSH >10 mIU/ml.
Previous intrauterine insemination (IUI )cycles,
Liver or kidney diseases,
Hypersensitivity to the used medications.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Walid Anwar Murad, MD
Organizational Affiliation
Gynecology & Obstetric Department, Faculty of Medicine, Benha University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Dual FSH/HCG Trigger in Letrozole Stimulated Intrauterine Insemination Cycles in Women With Unexplained Infertility
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