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

This study has been completed.
Sponsor:
Information provided by:
Tabriz University
ClinicalTrials.gov Identifier:
NCT00844350
First received: February 13, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted
  Purpose

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 .


Condition Intervention Phase
Ovarian Response
Drug: letrozole , oxytocin,hCG,clomiphene citrate
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Tabriz University:

Primary Outcome Measures:
  • number of follicles, endometrial thickness, and clinical pregnancy rate [ Time Frame: first ,second and third month ] [ Designated as safety issue: No ]

Enrollment: 177
Study Start Date: October 2006
Study Completion Date: October 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: letrozole+hCG Drug: letrozole , oxytocin,hCG,clomiphene citrate
No Intervention: letrozole+oxytocin Drug: letrozole , oxytocin,hCG,clomiphene citrate
No Intervention: letrozole+oxytocin+hCG Drug: letrozole , oxytocin,hCG,clomiphene citrate
No Intervention: clomiphene citrate +oxytocin Drug: letrozole , oxytocin,hCG,clomiphene citrate
No Intervention: clomiphene citrate +oxytocin+hCG Drug: letrozole , oxytocin,hCG,clomiphene citrate

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.

  Eligibility

Ages Eligible for Study:   17 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Manizhe sayyah melli, Tabriz university of medical scince
ClinicalTrials.gov Identifier: NCT00844350     History of Changes
Other Study ID Numbers: 8725
Study First Received: February 13, 2009
Last Updated: February 13, 2009
Health Authority: Iran: Ministry of Health

Keywords provided by Tabriz University:
Oxytocin
Letrozole
Induction of ovulation

Additional relevant MeSH terms:
Citric Acid
Oxytocin
Clomiphene
Enclomiphene
Zuclomiphene
Chorionic Gonadotropin
Letrozole
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents
Aromatase Inhibitors
Enzyme Inhibitors
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Fertility Agents, Female
Fertility Agents
Selective Estrogen Receptor Modulators

ClinicalTrials.gov processed this record on September 22, 2014