Infertility Clinical Trial
Official title:
Uterine Contractions and Mode of Progesterone in Frozen Embryo Transfer (FET) Cycles: Randomized Clinical Trial
NCT number | NCT02078869 |
Other study ID # | PIO-wave |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 15, 2015 |
Est. completion date | September 1, 2016 |
Verified date | April 2023 |
Source | Toronto Centre for Advanced Reproductive Technology |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 34 |
Est. completion date | September 1, 2016 |
Est. primary completion date | September 1, 2015 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 43 Years |
Eligibility | Inclusion Criteria: - Female patients in the reproductive age group (18-43 years) undergoing IVF FET cycle, blastocyst stage. Exclusion Criteria: - History of reaction to either one of the P4 medication - Current use of calcium channels blockers - Uterine factor infertility - Acupuncture therapy during current cycle |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Toronto Centre for Advanced Reproductive Technology |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Implantation Rate | Four weeks after embryo transfer- routine ultrasound for pregnancy confirmation and number of sacs will be performed and the implantation rate will be calculated as number of sacs divided by number of patients who had embryos transferred | The outcome of the study cycle- tested 4 weeks after the transfer |
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