Effect of a Multivitamin Supplement With Probiotic (Seidivid Ferty4®) on Oocyte Retrieval and Quality

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Reproductive Techniques, Assisted

Intervention / Treatment
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* Dietary Supplement: Seidivid Ferty4
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 34 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Seidivid Ferty4<br>Patients included in this group will be administered dietary supplement Seidivid Ferty4 (2 capsules per day, as a single dose) for at least 30 days prior to controlled ovarian hyperstimulation and until the day of the agonist trigger (GnRH a). | Dietary Supplement: Seidivid Ferty4<br>* The patient will start taking the study treatment (multivitamin supplement with probiotics) immediately after inclusion. Throughout the COH period of the protocol (usual mean duration: 11 days) the patient will continue taking the diatary supplement, without interruption until the day of the GnRH-agonist trigger.<br>|
| Placebo Comparator: Placebo<br>Patients included in this group will be administered placebo (2 capsules per day, as a single dose) for at least 30 days prior to controlled ovarian hyperstimulation and until the day of the agonist trigger (GnRH-a). | Other: Placebo<br>* The patient will start taking the study treatment (placebo) immediately after inclusion. Throughout the COH period of the protocol (usual mean duration: 11 days) the patient will continue taking the treatment (placebo), without interruption until the day of the GnRH-agonist trigger.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of oocytes retrieved | Total number of oocytes retrieved in the follicular puncture | Through study completion, an average of 42 days | 
| Number of mature (MII) oocytes retrieved | Total number of mature oocytes (metaphase II, or MII) retrieved in the follicular puncture | Through study completion, an average of 42 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of normal or good quality oocytes | Percentage of mature oocytes MII without dimorphisms respect to the total mature oocytes MII retrieved | Through study completion, an average of 42 days | 
| Rate of oocytes with dimorphisms | Percentage of mature oocytes MII with dimorphisms respect to the total mature oocytes MII retrieved | Through study completion, an average of 42 days | 
| Rate of oocytes with intra-cytoplasmic dimorphisms | Percentage of mature oocytes MII with intra-cytoplasmic dimorphisms respect to the total mature oocytes MII retrieved | Through study completion, an average of 42 days | 
| Rate of oocytes with extra-cytoplasmic dimorphisms | Percentage of mature oocytes MII with extra-cytoplasmic dimorphisms respect to the total mature oocytes MII retrieved | Through study completion, an average of 42 days | 
| Number of antral follicles at study inclusion | Ultrasound antral follicle count at study inclusion | Baseline | 
| Number of antral follicles at the time of COH start | Ultrasound antral follicle count at the time of controlled ovarian hyperstimulation (COH) start | Through COH start, an average of 30 days | 
| Number of follicles at the time of trigger administration | Ultrasound follicle count at the time of trigger administration | Through trigger administration, an average of 40 days | 
| Baseline fasting glucose | Fasting blood glucose at the time of study inclusion | Baseline | 
| Fasting glucose at the time of COH start | Fasting blood glucose at the time of controlled ovarian hyperstimulation (COH) start | Through COH start, an average of 30 days | 
| Baseline AST | Serum aspartate aminotransferase (AST) levels at the time of study inclusion | Baseline | 
| AST at the time of COH start | Serum aspartate aminotransferase (AST) levels at the time of controlled ovarian hyperstimulation (COH) start | Through COH start, an average of 30 days | 
| Baseline ALT | Serum alanine aminotransferase (ALT) levels at the time of study inclusion | Baseline | 
| ALT at the time of COH start | Serum alanine aminotransferase (ALT) levels at the time of controlled ovarian hyperstimulation (COH) start | Through COH start, an average of 30 days | 
| Baseline Cholesterol | Total cholesterol at the time of study inclusion | Baseline | 
| Cholesterol at the time of COH start | Total cholesterol at the time of controlled ovarian hyperstimulation (COH) start | Through COH start, an average of 30 days | 
| LH at the time of COH start | Plasma levels of luteinizing hormone (LH) at the time of controlled ovarian hyperstimulation (COH) start | Through COH start, an average of 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oocyte maduration, oocyte donation, dietary supplement