Does nifedipine improve implantation and pregnancy rates in women undergoing in-vitro fertilisation (IVF)/intracytoplasmic sperm injection (ICSI) cycles?

Phase 1

Completed

• Conditions: infertility; Reproductive Health and Childbirth - Fertility including in vitro fertilisation

• Registration Number: ACTRN12617000213347
• Lead Sponsor: Melbourne IVF

Brief Summary

o statistical differences in the implantation rate and the clinical pregnancy rate were detected between the placebo and the treatment groups. In addition, no statistical significance between the placebo and the treatment groups for any secondary outcomes were detected.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-02-09
• Study Completion: 2018-01-18
• Last Update Posted: 15 July 2019

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 93

Inclusion Criteria

* 18-45yo females undergoing IVF/ICSI cycles with either fresh or frozen embryo transfer.
* Baseline Blood Pressure: greater than, or equal to, 100/60, measured prior to ET

Exclusion Criteria

*Body mass index (BMI) > 38 kg/m2
*Early follicular phase (day 2-4) serum follicle stimulating hormone (FSH) level > 20 mIU/ml.
*Abnormal uterine cavity as evidenced by sonohysterogram or hysterosalpingography
*Any contraindication to being pregnant and carrying a pregnancy to term.
* Contraindication for the use of nifedipine, Estrogen and Progesterone suppositories.
* Patient being treated with other drugs that interact with cytochrome P450 activity: azole antifungals, cimetidine, cyclosporine, erythromycin, quinidine, terfenadine, warfarin, benzodiazepines, flecainide, imipramine, propafenone and theophylline.*Irregular heart beat or already being treated with another medication for high blood pressure.
*Any ovarian or abdominal abnormality that may interfere with adequate transvaginal sonography (TVS) evaluation.
*Administration of any investigational drugs within three months prior to study enrollment.
*Patient not able to communicate adequately with the investigators and to comply with the requirements of the entire study.
*Unwillingness to give written informed consent.
*Previous entry into this study.
*BP <100/60

Study & Design

• Study Type: Interventional
• Study Design: Not specified