Co-incubation of Oocytes With Sperm: Defining the Optimal Incubation Time

Infertility Clinical Trial

Official title:

Co-incubation of Oocytes With Sperm: Defining the Optimal Incubation Time

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04627545
• Other study ID #: 2010-ABU-010-ND
• Status: Recruiting
• Phase: N/A
• Start date: November 3, 2020
• Est. completion date: December 30, 2023

Study information

• Verified date: March 2023
• Source: ART Fertility Clinics LLC
• Contact: Neelke De Munck, PhD
• Phone: +971501982760
• Email: Neelke.demunck[@]artfertilityclinics.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The current pilot study aims to evaluate the fertilization rates between sibling oocytes subjected to short incubation (2h) versus overnight incubation (16-20h). As secondary objectives, the abnormal fertilization, embryo development, blastocyst biopsy and euploid rates will be analyzed.

Description:

All patients for whom at least 6 cumulus oocytes complexes (COCs) are assigned to IVF, with normal sperm parameters, are eligible for the study. An electronically generated randomization list will allocate the first half of the oocytes to one arm and the other half of the oocytes to the second arm. In case an odd number of oocytes will be inseminated, one extra oocyte will be allocated to the first arm. In this prospective observational pilot study, the fertilization potential of 40 patients will be evaluated.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 30, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 43 Years

Eligibility

Inclusion Criteria:

• Sperm parameters
• Sperm concentration before capacitation: >15 million per ml (WHO) Total motility (PR+NP %): >40 (WHO) Progressive motility (PR %):>32 (WHO)
• Sperm concentration after capacitation: >0.6 million per ml (not WHO defined) Progressive motility (PR %):>65 (WHO)
• =6 COCs assigned to IVF
• BMI =35 kg/m2
• Female age 18 to = 43 years
• All ovarian stimulation protocols
• Fresh ejaculates
• Abstinence duration 2-5 days
• Presence or absence of sperm morphology data: as we do not have a diagnostic sperm analysis for all patients, the presence or absence of >4% normal morphology (WHO) will not be taken into account, even with known low (<4%) normal morphology
• Couples requesting Preimplantation Genetic Testing for Aneuploidies
• Arab population

Exclusion Criteria:

• If the volume to be added after IVF is insufficient to perform IVF on all needed oocytes
• Presence of >1 million per ml round cells in the ejaculate
• If a couple's previous cycle was included in the study
• Previous history of fertilization failure
• Globozoospermia
• PCO according to the Rotterdam criteria
• Progesterone >1.5 ng/ml on the day of trigger

Related Conditions & MeSH terms

• Infertility

Intervention

Other:
• 2h exposure to sperm for IVF
Oocytes will only be briefly (2h) exposed to progressive motile sperm for insemination
• overnight exposure to sperm for IVF
Oocytes will be exposed for a longer duration (overnight, 16-20h) to progressive motile sperm for insemination

Locations

Country	Name	City	State
United Arab Emirates	ART Fertility Clinics	Abu Dhabi

Sponsors (1)

Lead Sponsor	Collaborator
ART Fertility Clinics LLC

Country where clinical trial is conducted

United Arab Emirates, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Normal fertilization rate	presence of two pronuclei per inseminated oocyte	2 days
Secondary	Number of COCs assigned to each group	number of oocytes, per patient, assigned to each exposure group	2 days
Secondary	Maturation rate	number of mature oocytes obtained in each arm	2 days
Secondary	Fertilization	Number of abnormally fertilized oocytes and failed fertilization	3 days
Secondary	Total fertilization failure	Number of cycles with complete fertilization failure (in one arm or in both arms)	3 days
Secondary	Embryo quality on day 3	defined by the Istanbul consensus (Alpha Scientists, 2011) The number of blastomeres and their division pattern, fragmentation, presence of compaction, vacuoles, granulation and nuclei will divide the embryos into 3 categories: good, fair or poor	5 days
Secondary	Embryo quality on day 5	defined by a modified model of Gardner and Schoolcraft,1999	8 days
Secondary	blastulation rate I	number of embryos reaching at least the BL1 stage/ number of oocytes assigned to that group: defined by a 1 (yes, the embryo is blastulating) or 0 (no, the embryo is not blastulating)	8 days
Secondary	blastulation rate II	number of embryos reaching at least the BL1 stage/ number of mature oocytes in that group: defined by a 1 (yes, the embryo is blastulating) or 0 (no, the embryo is not blastulating)	8 days
Secondary	Utilization rate	number of embryos that can be used for the patient (=number of embryos that can be biopsied)/number of oocytes assigned to the group	8 days
Secondary	Day of trophectoderm biopsy	Day at which the blastocyst reaches sufficient expansion to perform biopsy of trophectoderm cells	8 days
Secondary	Euploid rate	Number of genetically normal embryos per total number of blastocysts biopsied, stratified per day of biopsy	8 days
Secondary	Morphokinetic parameters	As embryos will be monitored in a time lapse imaging system, morphokinetic parameters will be compared between both exposure arms: o t2: the timing to two cells; t3: the timing to three cells; t4: the timing to four cells; t5: the timing to five cells; t8: the timing to eight cells; SC: starting to compact; M: the timing to morula; SB: starting to blastulate; B: reaching a BL3 according to Gardner and Schoolcraft, 1999; F: reaching a BL4 according to Gardner and Schoolcraft, 1999; cc2: t3-t2; s2: t4-t3	10 days
Secondary	Pregnancy outcome	dichotomous variable defined by the presence of ßhCG test of > 15IU 12-15 days after embryo transfer	60 days
Secondary	Biochemical pregnancy	dichotomous variable defined as a pregnancy in which the hCG levels start do decrease after 1 week	70 days
Secondary	Implantation rate	defined by the number of gestational sacs/number of embryos transferred; • Clinical pregnancy (yes or no) defined by the ultrasonographic visualization of one or more gestational sacs, including ectopic pregnancies	80 days
Secondary	Clinical pregnancy Fetal Heart beat positive	dichotomous variable defined by the ultrasonographic visualization of one or more gestational sacs, with fetal heart beat at 7 weeks.	80 days