Uterine Contractions and Mode of Progesterone in Frozen Embryo Transfer (FET) Cycles: Randomized Clinical Trial

NCT02078869 | Completed Results DMC

• 1 other identifier: PIO-wave
• Study Type: interventional
• Target: 34
• Locations: 0 countries
• Sites: N/A

Brief Summary

When patients undergo in vitro fertilization (IVF), they often make more embryos than it is safe to transfer back in the womb all at once. These excess embryos are frozen and stored for future use. Frozen embryo transfer (FET) is therefore an important option of IVF where there are extra embryos. FET should take place under ideal conditions when uterine receptivity and uterine endometrial lining thickness are at the appropriate developmental stage as the embryo. A common way of preparing the uterus for FET is by using medications (Estrogen and Progesterone) that imitate a normal menstrual cycle while monitoring the endometrial lining development by transvaginal ultrasound. Progesterone (P4) may be administered vaginally or intra-muscularly (IM). The mode of Progesterone administration is based upon local conventions, experts' opinion and patients' preferences. All the mentioned modalities are common in the daily practice of IVF clinics across the world. The current medical literature does not present high quality evidence for the superiority of one form of Progesterone administration over the other for FET. The investigators know that in fresh embryo transfer cycles where natural follicles continue to function and produce Progesterone as corpora lutea, there were no reported differences in pregnancy rates when luteal vaginal P4 was compared with IM P4 support, but the investigators do not have the same reassurance regarding frozen embryo transfers. The aim of this study is to compare vaginal versus IM route of administration of P4 for FET cycle in a well-designed trial. Since many outcome variables are possible, the investigators have chosen to concentrate in the one that might shed light on a possible biological difference between the two modes of Progesterone administration; uterine contractions. Uterine contractions have been previously recognized as a possible factor that compromises success rates in patients undergoing IVF treatments. Progesterone is considered a uterine relaxant and its levels in the blood versus the levels in the uterus differ by its mode of administration: blood levels are higher when given IM whereas uterine P4 concentrations are higher when given vaginally. The investigators are interested to see whether IM progesterone in frozen embryo transfers presents a different uterine contraction pattern than the vaginal administration.

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

• Number of Uterine Endometrial Contractions Per Minute

  The primary outcome will be the number of contractions per minute assessed over 5 minutes on the day of FET.

  on the day of frozen embryo transfer

Secondary Outcomes (1)

• Implantation Rate

  The outcome of the study cycle- tested 4 weeks after the transfer

Study Arms (2)

intramuscular Progesterone in oil

ACTIVE COMPARATOR

50mg of intramuscular Progesterone injection will be administered once daily for 6 days including the day of embryo transfer

Drug: Progesterone in oil

vaginal progesterone suppositories

ACTIVE COMPARATOR

200mg of progesterone suppositories will be administered 3 times a day for 6 days including the day of embryo transfer

Drug: vaginal progesterone suppositories

Interventions

Progesterone in oil DRUG

Daily administration of 50 mg of IM Progesterone

intramuscular Progesterone in oil

vaginal progesterone suppositories DRUG

Vaginal Promterium 200 mg , 3 times a day

Also known as: Prometrium

vaginal progesterone suppositories

Eligibility Criteria

• Age: 18 Years - 43 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female patients in the reproductive age group (18-43 years) undergoing IVF FET cycle, blastocyst stage.

You may not qualify if:

• History of reaction to either one of the P4 medication
• Current use of calcium channels blockers
• Uterine factor infertility
• Acupuncture therapy during current cycle

Sponsors & Collaborators

• Toronto Centre for Advanced Reproductive Technology: lead

MeSH Terms

Conditions

Infertility

Interventions

Progesterone; Oils

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; Lipids

Results Point of Contact

• Title: Robert F Casper, PI
• Organization: TCART

casper@lunenfeld.ca

416-972-0777

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor (University of Toronto)

Study Record Dates

• First Submitted: March 3, 2014
• First Posted: March 5, 2014
• Study Start: May 15, 2015
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2016
• Last Updated: April 12, 2023
• Results First Posted: April 12, 2023

Record last verified: 2023-04