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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Seidivid Ferty4 | Experimental | 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). |
|
| Placebo | Placebo Comparator | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Seidivid Ferty4 | Dietary Supplement | 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Good Quality Oocytes | Number of oocytes MII without dimorphisms | Through study completion, an average of 42 days |
| Number of Oocytes With Dimorphisms | Number of mature oocytes MII with dimorphisms |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Luis Quintero, Ph | NextFertility Valencia | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NextFertility | Valencia | 46009 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41361728 | Derived | Bonta S, Maggi S, Rodriguez R, Jimenez R, Villaquiran AM, Pla E, Fuentes R, Luque MD, Ferrer J, Quintero L. Ovovid trial: the effect of a probiotic micronutrients supplement on oocyte retrieval and quality in oocyte donors. A double blind, randomized controlled trial. J Assist Reprod Genet. 2026 Feb;43(2):603-613. doi: 10.1007/s10815-025-03763-4. Epub 2025 Dec 9. |
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There is no plan to make IPD available because the voluntary participating oocyte donors are healthy women and are not amenable to further follow-up.
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| ID | Title | Description |
|---|---|---|
| FG000 | Seidivid Ferty4 | 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). |
| FG001 | Placebo | 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Seidivid Ferty4 | 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). |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age data not available for 1 patient in placebo group |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Oocytes Retrieved | Total number of oocytes retrieved in the follicular puncture | Only patients who completed the study and underwent follicular puncture | Posted | Geometric Mean | Standard Deviation | oocytes retrieved | Through study completion, an average of 42 days |
|
42 days
Adverse events described by patients and recorded by the investigator at each control visit
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Seidivid Ferty4 | 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). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sleepiness | Nervous system disorders | Non-systematic Assessment | Mild sleepiness since the start of treatment. Causal relationship to treatment: possible |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ana Gavilán | SEID | +34 630928812 | agavilan@lab-seid.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 13, 2022 | Jul 23, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006379 | Helping Behavior |
| ID | Term |
|---|---|
| D012919 | Social Behavior |
| D001519 | Behavior |
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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.
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The study multivitamin product with probiotics (Seidivid Ferty4®) and placebo will be supplied as capsules with an identical external appearance packaged in blisters in a white box with no label, marked only with the study code and patient code.
|
| Placebo | Other | 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. |
|
| 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 | 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) | 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 | Through COH start, an average of 30 days |
| ALT After 30 Days of Treatment With Dietary Supplement. | Serum alanine aminotransferase (ALT) levels at the time of controlled ovarian hyperstimulation (COH) start | 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 | 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 |
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). |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Baseline Fasting Glucose | Fasting blood glucose at the time of study inclusion | Data not available for 47 participants | Mean | Standard Deviation | mg/dl |
|
| Number of Antral Follicles at Study Inclusion | Ultrasound antral follicle count at study inclusión | Data not available for 2 participants | Mean | Standard Deviation | antral follicles |
|
| Baseline AST | Serum aspartate aminotransferase (AST) levels at the time of study inclusión | Data not available for 18 participants | Mean | Standard Deviation | U/L |
|
| Baseline ALT | Serum alanine aminotransferase (ALT) levels at the time of study inclusión | Data not available for 18 participants | Mean | Standard Deviation | U/L |
|
| Baseline Cholesterol LDL | Cholesterol LDL at the time of study inclusión | Data not available for 18 participants | Mean | Standard Deviation | mg/dl |
|
| Baseline Cholesterol | Total cholesterol at the time of study inclusión | Data not available for 18 participants | Mean | Standard Deviation | mg/dL |
|
|
|
|
| Primary | Number of Mature (MII) Oocytes Retrieved | Total number of mature oocytes (metaphase II, or MII) retrieved in the follicular puncture | Only patients who completed the study and underwent follicular puncture | Posted | Geometric Mean | Standard Deviation | mature oocytes | Through study completion, an average of 42 days |
|
|
|
|
| Secondary | Number of Good Quality Oocytes | Number of oocytes MII without dimorphisms | Only patients who completed the study underwent follicular puncture and retrieved MII oocytes. One case was excluded because no mature oocytes were retrieved. | Posted | Mean | Standard Deviation | oocytes | Through study completion, an average of 42 days |
|
|
|
|
| Secondary | Number of Oocytes With Dimorphisms | Number of mature oocytes MII with dimorphisms | Only patients who completed the study and underwent follicular puncture, and who specified whether the oocytes had dysmorphisms. One case was excluded because no mature oocytes were obtained, and three cases were excluded because the number of dysmorphic oocytes was not specified. | Posted | Mean | Standard Deviation | oocytes | Through study completion, an average of 42 days |
|
|
|
|
| Secondary | Number of Follicles at the Time of Trigger Administration | Ultrasound follicle count at the time of trigger administration | Posted | Mean | Standard Deviation | follicle count | Through trigger administration, an average of 40 days |
|
|
|
|
| Secondary | Fasting Glucose After 30 Days of Treatment With Dietary Supplement. | Fasting blood glucose at the start of controlled ovarian hyperstimulation (COH) | Only patients with fasting glucose data recorded at baseline and at 30 days were analysed. | Posted | Mean | Standard Deviation | mg/dl | Through COH start, an average of 30 days |
|
|
|
|
| Secondary | AST After 30 Days of Treatment With Dietary Supplement. | Serum aspartate aminotransferase (AST) levels at the time of controlled ovarian hyperstimulation (COH) start | Only patients with AST data recorded at baseline and at 30 days were analysed. | Posted | Mean | Standard Deviation | U/L | Through COH start, an average of 30 days |
|
|
|
|
| Secondary | ALT After 30 Days of Treatment With Dietary Supplement. | Serum alanine aminotransferase (ALT) levels at the time of controlled ovarian hyperstimulation (COH) start | Only patients with ALT data recorded at baseline and at 30 days were analysed. | Posted | Mean | Standard Deviation | U/L | Through COH start, an average of 30 days |
|
|
|
|
| Secondary | Cholesterol After 30 Days of Treatment With Dietary Supplement. | Total cholesterol at the time of controlled ovarian hyperstimulation (COH) start | Only patients with total cholesterol data recorded at baseline and at 30 days were analysed. | Posted | Mean | Standard Deviation | mg/dl | Through COH start, an average of 30 days |
|
|
|
|
| Secondary | LH at the Time of COH Start | Plasma levels of luteinizing hormone (LH) at the time of controlled ovarian hyperstimulation (COH) start | Posted | Mean | Standard Deviation | mUI/ml | Through COH start, an average of 30 days |
|
|
|
|
| 0 |
| 98 |
| 0 |
| 98 |
| 2 |
| 98 |
| EG001 | Placebo | 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). | 0 | 98 | 0 | 98 | 0 | 98 |
|
| Skin reaction | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Mild skin eruptions appearing after 20 days of treatment. Relationship to treatment: possible. |
|
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| Unknown or Not Reported |
|
| Superiority |
| Fasting glucose at the start of COH compared to baseline fasting glucose. | t-test, 2 sided | <0.001 | Superiority |
| Superiority |
| AST at the start of COH compared to baseline AST. | t-test, 2 sided | 0.959877 | Superiority |
| Superiority |
| ALT at the start of COH compared to baseline ALT. | t-test, 2 sided | 0.968525 | Superiority |
| Superiority |
| Cholesterol at the start of COH compared to baseline cholesterol. | t-test, 2 sided | 0.127135 | Superiority |