The Effect of Oxytocin (OT) and Oxytocin Plus Human Chorionic Gonadotropin (hCG), in Cycles Induced by Letrozole or Clomiphene Citrate

NCT ID: NCT00844350

Last Updated: 2009-02-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 177 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2007-10-31

Brief Summary

The specific aims of this study were to assess whether letrozole as an aromatase inhibitor plus hCG or OT alone, or in combination compared with CC, improves ovarian response.Ethical design of this study is based on the ethical guidelines of the Iranian Medical and Health Ministry which is accepted by Tabriz medical university ethical committee .

Detailed Description

In a randomized controlled prospective clinical study, a total of 177 infertile women with CC+hCG-resistant PCOS included. The candidates were selected for this study in the clinics of Tabriz University of Medical Sciences, East Azarbayejan Province, North West of Iran, from Oct. 2006 to Sep. 2007. Infertile women who had chronic anovulation and classical PCOS with CC+hCG failure were age <40 y , had patent tubes on hysterosalpingography, and no other pelvic pathology, participated in this study. The patients who had hypersensivity to any oxytocic medications, history of cardiovascular disease, and took anti-hypertensive medications were excluded. In addition, women with blood pressure less than 90/60 mmHg, abnormal spermogram, anxiety, excess prolactin levels, and other causes of infertility were excluded. All participants were given adequate information, and consent was obtained from each participant.

The candidates were randomly divided into five groups including; letrozole + hCG (36 patients) (group 1), letrozole + OT (35 patients) (group 2), letrozole +OT + hCG (35 patients) (group 3), CC + OT (35 patients) (group 4), and CC + OT + hCG (36 patients) (group 5). Participants received letrozole 2.5mg at first month and 5mg at the second and third month. Also, CC was used 50 mg at the first month, to 150 mg at the third month to stimulate follicular growth. Oxytocin (OXYTIP; manufactured by IPDIC, Rasht, Iran), 5 IU and hCG (Choriomon; manufactured by IBSA Institute Biochimique SA, CH-6903 Lugano), 5000 IU were also administrated to induce ovulation. All patients underwent transvaginal sonography on day 13 to document the numbers of follicles and endometrial thickness. Participants were evaluated for three courses of intervention. Oxytocin was injected intramuscularly after CC or letrozol stimulation had induced enlarged ovarian follicles ( >18 mm in diameter to 30 mm). Decision to give a 5 IU dose of OT was made according to the pilot study (30). The patients who had larger follicles (more than 30mm in diameter), were withdrawn. The patients, who achieved pregnancy at the first or second month, were also withdrawn. All participants were evaluated for the levels of plasma progesterone one week after the injection of OT, hCG, or combination of them. A follow-up visit was arranged for each group every month at the second day of menstruation until 3 months after recruitment or at any time during the trial if pregnancy was achieved.

Conditions

Ovarian Response

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

letrozole+hCG

Group Type: NO_INTERVENTION

letrozole , oxytocin,hCG,clomiphene citrate

Intervention Type: DRUG

letrozole+oxytocin

Group Type: NO_INTERVENTION

letrozole , oxytocin,hCG,clomiphene citrate

Intervention Type: DRUG

letrozole+oxytocin+hCG

Group Type: NO_INTERVENTION

letrozole , oxytocin,hCG,clomiphene citrate

Intervention Type: DRUG

clomiphene citrate +oxytocin

Group Type: NO_INTERVENTION

letrozole , oxytocin,hCG,clomiphene citrate

Intervention Type: DRUG

clomiphene citrate +oxytocin+hCG

Group Type: NO_INTERVENTION

letrozole , oxytocin,hCG,clomiphene citrate

Intervention Type: DRUG

Interventions

letrozole , oxytocin,hCG,clomiphene citrate

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• infertile women who had chronic anovulation
• classical PCOS with CC+hCG failure
• age <40 y
• had patent tubes on hysterosalpingography
• no other pelvic pathology
• participated in this study

Exclusion Criteria

• hypersensitivity to any oxytocic medications
• history of cardiovascular disease
• took anti-hypertensive medications were excluded.
• women with blood pressure less than 90/60 mmHg
• abnormal spermogram
• anxiety
• excess prolactin levels
• other causes of infertility were excluded

• Minimum Eligible Age: 17 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Tabriz University

OTHER

Sponsor Role: lead

Responsible Party

Tabriz university of medical scince

Other Identifiers

8725

Identifier Type: -

Identifier Source: org_study_id