Luteal Phase Progesterone in IUI and Gonadotropin Cycles

NCT01941875 | Completed Phase 3

• 1 other identifier: Pro00032793
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Clinical pregnancy rate

  Presence of a fetal heart beat after 6 weeks gestational age

  After 6 weeks gestational age

Secondary Outcomes (3)

• Biochemical Pregnancy

  After 6 weeks gestational age

• Non-viable Pregnancy

  After 6 weeks gestational age

• Multiple Pregnancy

  After 6 weeks gestational age

Study Arms (2)

No Luteal Support

NO INTERVENTION

Control group: No luteal phase support or medication will be used

Luteal Vaginal Progesterone

EXPERIMENTAL

Experiment group: Vaginal progesterone for luteal support beginning the first day after IUI

Drug: Progesterone Effervescent Vaginal Tablets

Interventions

Progesterone Effervescent Vaginal Tablets DRUG

Experimental

Also known as: Endometrin 100 mg twice daily

Luteal Vaginal Progesterone

Eligibility Criteria

• Age: 21 Years - 43 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

Fertility & Womens Endocrine Clinic, Royal Alexandra Hospital

Edmonton, Alberta, T5H 3V9, Canada

Location

MeSH Terms

Conditions

Infertility

Interventions

Progesterone

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Corpus Luteum Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progesterone Congeners; Gonadal Steroid Hormones

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2013
• First Posted: September 13, 2013
• Study Start: July 1, 2014
• Primary Completion: September 30, 2016
• Study Completion: September 30, 2016
• Last Updated: July 18, 2022

Record last verified: 2022-07

Locations

CA (1)