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OpenTrials
Completed

NCT Number: NCT04576546

Inositols and FSH in IVF

Ovarian hyperstimulation syndrome (OHSS), although quite uncommon, represents the most serious complication of ovulation induction during in-vitro fertilization (IVF) protocols. The syndrome is triggered by exaggerated ovarian response to gonadotropins, which eventually leads to pathological manifestations that range from mild symptoms, such as abdominal discomfort, to life-threatening complications in the most severe cases. Prevention is paramount during fertilization programs and requires assessment of risk factors and close monitoring of risk markers. Clinicians quite generally consider unusually elevated estrogen levels as both indicator for OHSS and one possible etiological factor. In this scenario, myo-inositol (MYO) treatment proved to reduce the amount of FSH units and the duration of the stimulation protocol, decreasing the risk of OHSS onset. On the other hand, inconclusive evidence is available about the effect of D-chiro-inositol (DCI) supplementation within assisted reproductive treatments. The aim of the proposed pilot study is to assess the effect of DCI supplementation on the doses of FSH used in IVF-ET protocols, also with respect to MYO treatment.

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Clinica Alma Res

Roma, 00198, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women undergoing IVF-ET procedure
  • HOMA-IR index < 2.0
  • AMH in the range 1.0 - 2.0 ng/ml

Exclusion criteria

  • History of cancelled IVF cycles
  • BMI < 20 kg/m2 or ≥ 30 kg/m2
  • Diagnosis of PCOS
  • Thyroid diseases
  • Presence of co-morbidities

Treatment and study plan

D-chiro-inositol

Dietary Supplement

Supplementation of D-chiro-inositol (1000 mg/die), starting at least 4 weeks before rFSH administration

Myo-Inositol

Dietary Supplement

Supplementation of myo-inositol (4 g/die), starting at least 4 weeks before rFSH administration

Primary outcomes

  1. FSH units/retrieved oocyte

    Time frame: 1 day (single time-point at ovulation)

    number of IU of recombinant FSH administered, normalized on the number of oocytes retrieved during the pick-up

Secondary outcomes

  1. Total FSH (IU)

    Time frame: 1 day (single time-point at ovulation)

    total number of FSH IU used in the stimulation protocol

  2. Duration of the stimulation

    Time frame: 1 day (single time-point at ovulation)

    Number of days of the stimulation protocol till pick-up

  3. number of viable oocytes

    Time frame: 1 day (single time-point at oocyte pick-up)

    number of retrieved oocytes eligible for fortilization

  4. oocyte quality

    Time frame: 1 day (single time-point at oocyte pick-up)

    classification of oocyte quality before fertilization

  5. embryo quality

    Time frame: 1 day (single time-point at embryo transfer)

    evaluation of the quality of embryos after fertilization, before transfer

Sponsors and collaborators

Lead sponsor

Lo.Li.Pharma s.r.l

Industry

Registry information

Official study title

Use of Inositols Within IVF Protocols to Reduce Gonadotropin Administration

Important dates

Study start
2020
Primary completion
2023
Study completion
2024
First posted
Oct 6, 2020
Registry last updated
Jul 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.