Clinical trial NCT06619379: The Effect of Vaginal Speculum Type and Retention Time on Pregnancy Outcomes During the Embryo Transfer Process
Official title: The Effect of Vaginal Speculum Type and Retention Time on Pregnancy Outcomes During the Embryo Transfer Process
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pregnancy Rates
Keywords: IVF embryo transfer speculum retention
Lead sponsor: Eurofertil IVF Health Center
Sponsor class: OTHER
First posted: 2024-10-01
Enrollment: 200
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Investigators aim to investigate possible affects of a speculum material and retention strategy on IVF pregnancy results. The study is planned as a prospective, randomized control trial. All of the clinical managements, including the embryo transfers, will be performed by the same gynecologist for homogeneity of the study. Only the cases with good implantation potentials are going to be included. Therefore, transfers with cleavage embryos and blastocysts rather than good and top quality will be excluded. All patients included to final statistical analysis will receive the same luteal support.

Detailed description: Participants will be included among the 20 - 40 years old women applying to for IVF. Women with mullerian anomalies and couples with chromosomal abnormalities will be excluded. Histrory of recurrent implantation failure, thin endometrium will also be considered as exclusion criterias. Participants who are initially included in the study will be excluded either the demanded preimplantation genetik testing for aneuploidy optionally, or if the embryo transfer is performed under general anesthesia or the embryo transfer is recorded as difficult transfer.

The participants included in the study will be randomised for the speculum material ( metal or plastic) and also for the retention time of the speculum out of the vagina. Just immediately before applying the speculum to the patient, the material temperature will be measured and recorded with a thermometer capable of digital and object measurement.

All of the transfers will be performed with the same technique. After the embryo transfer is made and the transfer catheter is withdrawn, the speculum will be extracted according to the randomization. If the speculum is not extracted immediately, the chronometer will be started and the extraction will be done either in the 60. second or 420. second ( 7 minutes) according to the randomization . As there are two speculum materials and three retention time arms in the design, a total of 6 groups will be formed after crossover. Data gained in this way will be analyzed and their demographic data and embryological parameters will be evaluated and the implantation rates, pregnancy rates and clinical pregnancy rates of the patients will be determined.

Eligibility criteria: Inclusion Criteria:

* women aged 20-40
* cases that good and top quality embryos are achieved for embryo trasnfer

Exclusion Criteria:

* recurrent implantation failure
* any known genetic problems of couple
* any known mullein anomalies
* PGT-A cases
* thin endometrium

Primary outcomes:
measure: pregnacy rates
timeFrame: Beta-HCG test will be taken on the 12th day of the embryo transfer
Secondary outcomes:
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: Eurofertil
Study officials:
References: