Dual FSH/HCG Trigger in Letrozole Stimulated Intrauterine Insemination Cycles in Women With Unexplained Infertility

Benha University

Status and phase: Completed; Phase 3

Conditions: Unexplained Infertility

Treatments: Drug: FSH co-trigger; Drug: Letrozole; Drug: Human chorionic gonadotropin

Study type: Interventional

Funder types: Other

Identifiers

NCT02739516

Benha 125

Details and patient eligibility

About

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 .

Full 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.

Enrollment: 108 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

108 participants in 2 patient groups

Control

Active Comparator group

Description:

In letrozole stimulated cycle: On the day of ovulation trigger the patient received standard dose of Human chorionic gonadotropin (10,000 IU).

Treatment:

Drug: Letrozole

Drug: Human chorionic gonadotropin

Study

Experimental group

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 .

Treatment:

Drug: Letrozole

Drug: FSH co-trigger

Drug: Human chorionic gonadotropin