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Luteal Phase Progesterone in IUI and Gonadotropin Cycles

The Effect of Luteal Phase Support on Pregnancy Rate in Intrauterine Insemination Cycles Following Ovarian Stimulation With Gonadotropins

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01941875
Enrollment
300
Registered
2013-09-13
Start date
2014-07-31
Completion date
2016-09-30
Last updated
2022-07-18

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

Conditions

Infertility

Keywords

controlled ovarian hyperstimulation, gonadotropins, intrauterine insemination, infertility, luteal progesterone

Brief summary

This is a study of patients undergoing Controlled Ovarian Hyperstimulation (COH) with Gonadotropins and Intrauterine Insemination (IUI) at a Fertility Clinic. Infertility is a common problem, and a popular method of therapy is to inject sperm through the cervix and into the uterus, a procedure known as IUI. In conjunction with IUI, injectable medications (gonadotropins) are used to stimulate the ovaries to produce more than one egg per cycle in a process called COH. Vaginal progesterone is used for luteal support in in vitro fertilization therapy and has been proven to effect pregnancy rates. However, the role of progesterone in COH is still unclear. In this study, the investigators want to examine the effect of giving vaginal progesterone after COH with IUI on pregnancy rates. The investigators want to study if luteal vaginal progesterone results in a higher pregnancy rate compared to no progesterone therapy in COH with IUI. At present, fertility centres vary in the use of progesterone after insemination, most likely due to the lack of studies on this subject. At the Fertility Clinic all patients undergoing COH with injectable medications and IUI, regardless of whether they are in the study, have a baseline transvaginal ultrasound and blood tests. Patients start the injectable medications for COH until the ovarian follicles are large enough, then a medication to release the eggs is given. The IUI is done approximately 36 hours later. The day after the IUI, study patients will be given vaginal progesterone while the control patients will receive no progesterone. All patients will be followed until a pregnancy test is done and a viable foetus is confirmed by ultrasound.

Interventions

DRUGProgesterone Effervescent Vaginal Tablets

Experimental

Sponsors

University of Alberta
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
21 Years to 43 Years
Healthy volunteers
Yes

Inclusion criteria

* Couples with infertility * Confirmed bilateral tubal patency * More than 10 million motile sperm available for IUI

Exclusion criteria

* Subjects declining enrollment * Allergies to prescribed vaginal progesterone * Subjects less than 21 years old or over 43 years old

Design outcomes

Primary

MeasureTime frameDescription
Clinical pregnancy rateAfter 6 weeks gestational agePresence of a fetal heart beat after 6 weeks gestational age

Secondary

MeasureTime frameDescription
Biochemical PregnancyAfter 6 weeks gestational ageBiochemical pregnancy rate
Non-viable PregnancyAfter 6 weeks gestational ageNon-viable pregnancy rate
Multiple PregnancyAfter 6 weeks gestational ageMultiple pregnancy rate

Countries

Canada

Outcome results

None listed

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