Unexplained Infertility
Conditions
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.
Interventions
DRUGHuman chorionic gonadotropin
In letrozole stimulated cycle; Human chorionic gonadotropin ( hCG) 10000 IU was given intramuscular when the mean ovarian follicle diameter was ≥18 mm.
DRUGFSH co-trigger
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.
DRUGLetrozole
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.
Sponsors
Benha University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical pregnancy rate per cycle (PR/C) and per woman (PP/W) | Throughout the study completion; up to 3 months | Achievement of clinical pregnancy defined as the presence of an intrauterine gestational sac with a pulsating fetal heart beat on ultrasound |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of ovarian hyperstimulation syndrome (OHSS) | Throughout the study completion; up to 3 months | Number of participants developed ovarian hyperstimulation syndrome (OHSS) per all women received intervention |
| Multiple pregnancies | Throughout the study completion; up to 3 months | Number of participants had multiple pregnancy per women achieved pregnancy . |
| The live birth rate per woman (LB/W). | Throughout the study completion; up to 2 year | Number of live birth per women receiving intervention. |
Outcome results
None listed