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Does nitric oxide donors increases pregnancy rate in patients undergoing intrauterine insemination for unexplained infertility?

Prospective randomized controlled pilot clinical study to evaluate the effect of nitric oxide donors treatment on pregnancy rate in patients with unexplained infertility undergoing intrauterine insemination

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12613001124729
Enrollment
60
Registered
2013-10-09
Start date
2013-10-07
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Unexplained infertility is failure to get pregnant after one year of marriage in spite of normal semen analysis, patent fallopian tubes and normal ovulation. Good blood flow to the uterus is essential for successful implantation and pregnancy. Nitric oxide donors are drugs the release nitric oxide in the body and acts as vasodilators and perfusion enhancer. In this study we tested if its administration increases uterine blood flow and pregnancy rate in unexplained infertility patients treated with ovarian stimulation and intrauterine insemination

Interventions

unexplained infertility patients were randomized to a control group and a study group. The control group was treated with ovarian stimulation and intrauterine insemination and study group received the same treatment in addition to 20 mg isosorbid mononitrate tablet once daily applied vaginally starting from the fifth day of the cycle with the start of ovarian stimulation till diagnosis of pregnancy in a case of missed period or occurrence of menstruation. Patients were monitored during treatment

unexplained infertility patients were randomized to a control group and a study group. The control group was treated with ovarian stimulation and intrauterine insemination and study group received the same treatment in addition to 20 mg isosorbid mononitrate tablet once daily applied vaginally starting from the fifth day of the cycle with the start of ovarian stimulation till diagnosis of pregnancy in a case of missed period or occurrence of menstruation. Patients were monitored during treatment by vaginal ultrasound and adherence to treatment was confirmed through drug tablet return

Sponsors

Benha university hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
20 Years to 30 Years
Healthy volunteers
No

Inclusion criteria

Unexplained infertility patients defined as the absence of a definable cause for a couple's failure to achieve pregnancy after 12 months of attempting conception despite a thorough evaluation. Inclusion criteria includes: 1- Normal semen analysis. 2- Patent fallopian tubes by HSG and laparoscopy when indicated. 3- Normal ovulation and luteal phase by serum progesterone at cycle days 21-23 of > 10 ng/ml.

Exclusion criteria

Patients receiving vasodilators.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026