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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
196
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.
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.
NextFertility
Valencia, Spain
Number of Oocytes Retrieved
Total number of oocytes retrieved in the follicular puncture
Time frame: 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
Time frame: Through study completion, an average of 42 days
Number of Good Quality Oocytes
Number of oocytes MII without dimorphisms
Time frame: Through study completion, an average of 42 days
Number of Oocytes With Dimorphisms
Number of mature oocytes MII with dimorphisms
Time frame: Through study completion, an average of 42 days
Number of Follicles at the Time of Trigger Administration
Ultrasound follicle count at the time of trigger administration
Time frame: Through trigger administration, an average of 40 days
Fasting Glucose After 30 Days of Treatment With Dietary Supplement.
Fasting blood glucose at the start of controlled ovarian hyperstimulation (COH)
Time frame: Through COH start, an average of 30 days
AST After 30 Days of Treatment With Dietary Supplement.
Serum aspartate aminotransferase (AST) levels at the time of controlled ovarian hyperstimulation (COH) start
Time frame: Through COH start, an average of 30 days
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ALT After 30 Days of Treatment With Dietary Supplement.
Serum alanine aminotransferase (ALT) levels at the time of controlled ovarian hyperstimulation (COH) start
Time frame: Through COH start, an average of 30 days
Cholesterol After 30 Days of Treatment With Dietary Supplement.
Total cholesterol at the time of controlled ovarian hyperstimulation (COH) start
Time frame: 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
Time frame: Through COH start, an average of 30 days