BridgeMD
New treatment option for Infertility (IVF Patients)
Official title Standardization of Variable Conditions of Embryo Transfer Into the Uterine Cavity in the Procedure of Medically Assisted Procreation in Humans
ClinicalTrials.gov ID: NCT07396181
What this study is testing
- What it's testing
- The EFECT study is a clinical trial designed to determine whether improving the consistency of embryo transfer procedures can increase pregnancy success in patients undergoing frozen embryo transfer (cryoET). While laboratory techniques for fertilization, embryo culture, and selection have advanced significantly, the process of transferring embryos to the uterus remains variable and depends on small procedural differences, such as temperature changes, mechanical forces, timing, and individual operator techniques.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 38, women only
You may be able to join if
- The patient and her partner gave written, informed consent to participate in the clinical trial.
- The patient underwent a medically assisted procreation procedure using IVF or ICSI in accordance with the applicable law, did not have a fresh...
- You and your partner are not currently taking part in or have not participated in any other clinical trial in the last 6 months.
- The patient's age on the day of screening ranges from ≥18 to ≤38 years.
- The patient's BMI on the day of screening ranges from ≥18 to \< 30.
You likely can't join if
- Failure to meet the inclusion criteria.
- The patient was found to have abnormalities in the anatomical structure of the uterus and reproductive tract, which, according to the researcher...
- The patient was diagnosed with endometrial polyp(s).
- The patient was diagnosed with submucosal or intramural uterine fibroids.
- The patient was diagnosed with fallopian tube hydromas.
- The patient was diagnosed with ≥3 endometriosis.
See the full eligibility criteria
Who can join
- The patient and her partner gave written, informed consent to participate in the clinical trial.
- The patient underwent a medically assisted procreation procedure using IVF or ICSI in accordance with the applicable law, did not have a fresh transfer, has all frozen embryos in the blastocyst stage, of which at least...
- You and your partner are not currently taking part in or have not participated in any other clinical trial in the last 6 months.
- The patient's age on the day of screening ranges from ≥18 to ≤38 years.
- The patient's BMI on the day of screening ranges from ≥18 to \< 30.
- Both partners have normal infectious tests performed 6 months before ET and bacteriological tests performed one month before ET.
- The patient has had IVF or ICSI embryo culture performed in an incubator with a Time Lapse monitoring system and an Artificial Intelligence system (or if not, the embryo will be placed in the EmbryoScope after thawing)...
- The patient has a normal uterus and endometrium at least 7 mm on ET.
- The patient must be prepared for cryotransfer in the ovulatory cycle with natural or induced letrozole, and after ovulation in the current cycle, take a progesterone preparation at the doses specified above for luteal...
- On the day of transfer (5th day after ovulation), the patient must have at least one thawed, developed embryo of good quality - pre-frozen blastocyst 3.2.2 thawed according to the highest AI rating.
- The patient must be qualified by the doctor for the procedure embryo transfer on day 5 after ovulation.
- Embryo transfer was performed without general anesthesia or other procedures and/or additional antispasmodic drugs prior to transfer (e.g. oxytocin antagonist) with the exception of routine preparation (drotaverine 1...
What rules you out
- Failure to meet the inclusion criteria.
- The patient was found to have abnormalities in the anatomical structure of the uterus and reproductive tract, which, according to the researcher, could reduce the chances of getting pregnant.
- The patient was diagnosed with endometrial polyp(s).
- The patient was diagnosed with submucosal or intramural uterine fibroids.
- The patient was diagnosed with fallopian tube hydromas.
- The patient was diagnosed with ≥3 endometriosis.
- The patient or her partner is a carrier of a genetic defect that may have an impact on lowering fertility.
- The patient or her partner is currently or has been undergoing cancer treatment in the past, which may have had a negative impact on fertility.
- The patient has had 1 unsuccessful embryo transfer in the past, which means no clinical pregnancy.
- During the trial transfer in the preceding cycle, difficulties in entering the uterine cavity (the so-called difficult transfer) were found or if the patient had had an embryo transfer in the past and it was described...
- Embryos are formed from eggs after PBB (polar body biopsy) of oocytes have been examined or have undergone genetic testing of embryos.
- The embryos were formed from oocytes after cryopreservation.
- Semen was obtained for a procedure other than normal ejaculation (retrograde bladder ejaculation, epididymis biopsy, testicular biopsy, M-TESE).
- The patient did not take progesterone for luteal phase supplementation.
- Inability to perform embryo transfer on day 5 after ovulation due to medical or random reasons.
- The patient has indications for general anesthesia or pre-transfer antispasmodic procedure/medication (oxytocin receptor antagonist other than Drotaverine, or others that may affect implantation (intralipid, neupogen...
- The patient is to have an incision made in the AH areola before the ET procedure.
- The patient wants to have Embryoglue used for transfer.
- The patient takes heparin, Clexane, Acesan, Relanium drugs on and after embryo transfer.
The study team makes the final eligibility decision.
Where it's taking place
- Warsaw, Poland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 38 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Warsaw, Poland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.