Clinical trial NCT05473039: Effect of a Multivitamin Supplement with Probiotic (Seidivid Ferty4®) on Oocyte Retrieval and Quality
Official title: OvoVid Study: Effect of a Multivitamin Supplement with Probiotic (Seidivid Ferty4®) on Oocyte Retrieval and Quality in Oocyte Donors. Double-blind Randomized Placebo-controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Reproductive Techniques, Assisted
Keywords: oocyte maduration
oocyte donation
dietary supplement
Lead sponsor: SEID S.A.
Sponsor class: INDUSTRY
First posted: 2022-07-25
Enrollment: 210
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 34
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a single-center, randomized, double-blind, placebo-controlled clinical trial with a dietary supplement with probiotics, with two parallel group of subjects.

Based on previous studies, considering this study as a non-inferiority versus placebo study the calculated sample size of subjects is 210 (105 subject for each arm).

Once the informed consent is signed, the patient will be assigned a patient code and will be given the treatment box (white and with no label) corresponding to her code. The patient will start taking the study treatment (multivitamin supplement with probiotics or placebo) immediately after inclusion. Throughout the COH period the patient will continue taking the study supplement and will undergo the regular ultrasound controls of the egg donation program for evolutive control of the number and growth of follicles, without interruption until the day of the GnRH-agonist trigger.
Primary purpose: TREATMENT

Brief summary: This study evaluates the effect of pretreatment with a multivitamin supplement with probiotics (Seidivid Ferty4®) on oocyte retrieval in normo-responder patients undergoing controlled ovarian hyperstimulation (COH) for oocyte donation, considering both the total number of oocytes retrieved and the number of mature oocytes retrieved, that is, in metaphase II (MII).

Detailed description: Patients will be recruited on the day they are going to start the egg donation program. The patient will start taking the study treatment (multivitamin supplement with probiotics or placebo) immediately after inclusion and will call the site to initiate the oocyte donation protocol approximately 30 days after enrollment. Throughout the COH period of the protocol the patient will continue taking the study supplement (or placebo), without interruption until the day of the GnRH-agonist trigger. The administration of the agonist will be as a single dose, 36 hours before follicular puncture for the retrieval of mature eggs. Then, the retrieved oocytes will be denuded and examined by light microscopy to assess their quality. The evaluation will carried out by two different embryologists, blinded to the study protocol.

Eligibility criteria: Inclusion Criteria:

* Women undergoing COH for egg donation cycles
* Signing of Informed Consent
* Age 18-34 years
* Body mass index between 18-29.9 kg/m2
* Meet the criteria for inclusion in the oocyte donation program of the Next Fertility center
* Ultrasound antral follicle count before COH of ≥15 follicles

Exclusion Criteria:

* Patients excluded from the oocyte donation program
* Untreated sexually transmitted disease, HIV, HCV, HBV positive serology
* Blood disorders, neurodegenerative/psychiatric diseases, fragile X syndrome, oncological diseases, endometriosis.
* Polycystic ovary syndrome
* Oligomenorrhea (\<1 menstrual cycle in 3 months)
* Diabetic patients

Primary outcomes:
measure: Number of oocytes retrieved
timeFrame: Through study completion, an average of 42 days
measure: Number of mature (MII) oocytes retrieved
timeFrame: Through study completion, an average of 42 days
Secondary outcomes:
measure: Rate of normal or good quality oocytes
timeFrame: Through study completion, an average of 42 days
measure: Rate of oocytes with dimorphisms
timeFrame: Through study completion, an average of 42 days
measure: Rate of oocytes with intra-cytoplasmic dimorphisms
timeFrame: Through study completion, an average of 42 days
measure: Rate of oocytes with extra-cytoplasmic dimorphisms
timeFrame: Through study completion, an average of 42 days
measure: Number of antral follicles at study inclusion
timeFrame: Baseline
measure: Number of antral follicles at the time of COH start
timeFrame: Through COH start, an average of 30 days
measure: Number of follicles at the time of trigger administration
timeFrame: Through trigger administration, an average of 40 days
measure: Baseline fasting glucose
timeFrame: Baseline
measure: Fasting glucose at the time of COH start
timeFrame: Through COH start, an average of 30 days
measure: Baseline AST
timeFrame: Baseline
measure: AST at the time of COH start
timeFrame: Through COH start, an average of 30 days
measure: Baseline ALT
timeFrame: Baseline
measure: ALT at the time of COH start
timeFrame: Through COH start, an average of 30 days
measure: Baseline Cholesterol
timeFrame: Baseline
measure: Cholesterol at the time of COH start
timeFrame: Through COH start, an average of 30 days
measure: LH at the time of COH start
timeFrame: Through COH start, an average of 30 days
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: NextFertility
Study officials:
affiliation: NextFertility Valencia
name: Luis Quintero, Ph
role: STUDY_DIRECTOR
References: