Comparison of pregnancy rate in single versus double Intrauterine Insemination (IUI) when polycystic ovarian syndrome or unexplained, mild male factor infertility is present.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT201307231306N7

Enrollment

580

Registered

2013-08-03

Start date

2013-06-22

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

Ovarian dysfunction. Polycystic ovarian syndrome

Interventions

Intervention 1: Ovulation induction using (1) tablets containing clomiphene citrate and letrozole, (2) injections including HMG and HCG or (3) both tablets and injection followed by single step I

Treatment - Devices

Ovulation induction using (1) tablets containing clomiphene citrate and letrozole, (2) injections including HMG and HCG or (3) both tablets and injection followed by single step IUI at 36 ho

Ovulation induction using: (1) tablets containing clomiphene citrate and letrozole, (2) injections including HMG and HCG or (3) both tablets and injection followed by double step IUI at 18 h

Eligibility

Sex/Gender

Female

Age

35 Years to 45 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: base serum level of FSH<12 mIu/l; females with polycystic ovarian syndrome who have not become pregnant despite six times of ovulation induction and having a suitable ovum.Females whose male partners have unexplained, mild male factor infertility; have no severe medical illness; no obstruction in tubes; no uterine anomaly. Exclusion criteria: existence of less than 2 or more than 5 ovarian follicles; any severe medical illness; females with ovarian cysts greater than 15mm after 3rd day following menstruation (diagnosed using transvaginal sonography).

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Pregnancy. Timepoint: 14 days after IUI. Method of measurement: Serum BHCG level assessment.	—

Secondary

Measure	Time frame
Pregnancy outcome. Timepoint: 14 days after IUI. Method of measurement: Serum BHCG level assessment.;Diagnosis of intrauterine pregnancy. Timepoint: 7th week of pregnancy. Method of measurement: Fetal Heart Rate (FHR) (transvaginal sonography).;Frequency of complications (abortion, ectopic pregnancy, multifetal gestation). Timepoint: Completion of treatment and follow up period. Method of measurement: Diagnosis of ectopic pregnancy and.	—

Measure

Time frame

Pregnancy outcome. Timepoint: 14 days after IUI. Method of measurement: Serum BHCG level assessment.;Diagnosis of intrauterine pregnancy. Timepoint: 7th week of pregnancy. Method of measurement: Fetal Heart Rate (FHR) (transvaginal sonography).;Frequency of complications (abortion, ectopic pregnancy, multifetal gestation). Timepoint: Completion of treatment and follow up period. Method of measurement: Diagnosis of ectopic pregnancy and.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactRomina Rashid Shomali

Guilan University of Medical Sciences

Rominashomali@gmail.com+98 13 1322 5624

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026