Effect of Luteal Progesterone Support on Pregnancy Rates With Combined Clomid/ Gonadotropin & IUI

A Prospective Randomized Trial to Study the Effect of Luteal Progesterone Support on Pregnancy Rates in Combined Clomiphene Citrate and Gonadotropin Ovulation Induction Protocol With Intrauterine Insemination.

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02510534

Enrollment

520

Registered

2015-07-29

Start date

2015-07-31

Completion date

2016-04-30

Last updated

2016-09-23

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

Conditions

Pregnancy

Brief summary

Detailed description

To determine the difference in clinical pregnancy rates with and without luteal progesterone support in a young reproductive aged population having undergone ovulation induction with combined clomiphene citrate and gonadotropin protocol with intrauterine insemination. Patients will be randomized in a treatment arm or control arm. The treatment arm receives the luteal progesterone support and the control arm does not. Each arm will have 260 patients.

Interventions

DRUGMenopur 150 international units

Menopur 150 international units given x 1 dose

DRUGEndometrin 100 mg

Endometrin 100mg twice daily x 14 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 37 Years

Healthy volunteers

Yes

Inclusion criteria

* Age 18-37 * BMI 19-34 kg/m2 * Day 2-3 Follicle stimulating hormone (FSH) less than 10IU/mL * Estradiol (E2) less than 80 pg/mL * Anti-mullerian hormone (AMH) more than 1.5 ng/mL; or antral follicle count (AFC) up to 10 * Two patent fallopian tubes confirmed by hysterosalpingogram (HSG) or chromopertubation * Normal uterine cavity confirmed by HSG, saline sonohysterogram (SIS) or hysteroscopy

Exclusion criteria

* Severe male factor (total count less than 10 million sperm) * Systemic diseases not limited to diabetes * Pregnancy within 3 months * More than 1 prior cycle of gonadotropin treatment * Any ovarian cyst \>15mm that has persisted for \> 1 month * Endometrioma and/or Endometriosis-stage III or IV * Submucosal uterine fibroids; untreated endometrial polyps \>1 cm;abnormal reproductive tract bleeding * Intolerance or allergy to study drug * Substance abuse (including alcohol and tobacco) * History of chemotherapy (except for gestational conditions) or radiotherapy * Minors and those adults not capable of consenting on their own

Design outcomes

Primary

Measure	Time frame
Effect on Pregnancy rate measured by detectable embryonic cardiac activity	10 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026