Clinical trial NCT02739516: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Unexplained Infertility
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2016-04-15
Enrollment: 108
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Clinical pregnancy rate per cycle (PR/C) and per woman (PP/W)
timeFrame: Throughout the study completion; up to 3 months
Secondary outcomes:
measure: Frequency of ovarian hyperstimulation syndrome (OHSS)
timeFrame: Throughout the study completion; up to 3 months
measure: Multiple pregnancies
timeFrame: Throughout the study completion; up to 3 months
measure: The live birth rate per woman (LB/W).
timeFrame: Throughout the study completion; up to 2 year
Other outcomes:
Locations:
Study officials:
affiliation: Gynecology & Obstetric Department, Faculty of Medicine, Benha University
name: Ahmed Walid Anwar Murad, MD
role: PRINCIPAL_INVESTIGATOR
References: