Evaluation of the Effect of Melatonin on In Vitro Fertilization Success Rates in Women with Polycystic Ovary Syndrome and a History of Failed IVF

Evaluation of the Effect of Melatonin on In Vitro Fertilization (IVF) Success Rates in Women with Polycystic Ovary Syndrome (PCOS) and a History of Failed IVF Treatment

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20250225064853N3

Enrollment

100

Registered

2025-10-01

Start date

2025-10-23

Completion date

Unknown

Last updated

2025-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polycystic Ovary Syndrome (PCOS). Polycystic ovarian syndrome

Interventions

Intervention 1: Intervention group: In this study, the intervention group consists of pregnant women with polycystic ovary syndrome (PCOS) and a history of at least one failed IVF. This group will rec

Eligibility

Sex/Gender

Female

Age

20 Years to 40 Years

Inclusion criteria

Inclusion criteria: Age: Women aged 20-40 years Confirmed diagnosis of Polycystic Ovary Syndrome (PCOS): Based on Rotterdam criteria History of failed IVF: At least one failure of IVF (no clinical pregnancy despite embryo formation and transfer) Willingness to cooperate: Willingness to fully cooperate throughout the study and follow-up

Exclusion criteria

Exclusion criteria: Infertility due to other causes (male, tubal) Chronic diseases Use of drugs that interact with melatonin (e.g., fluvoxamine, cimetidine, warfarin, and sedatives) Employment in safety-sensitive jobs (driving, industrial operations, or surgery) Pregnancy

Design outcomes

Primary

Measure	Time frame
Mature Oocyte Count. Timepoint: Before intervention (prior to ovarian stimulation) and after intervention (oocyte retrieval). Method of measurement: Number of mature oocytes (count).;Fertilization Rate. Timepoint: After sperm injection into oocytes (ICSI) and follow-up until embryo culture. Method of measurement: Fertilization success rate (percentage).;Embryo Quality. Timepoint: After embryo culture in the laboratory (Day 3 or 5 after oocyte retrieval). Method of measurement: Embryo grading (Grade A, B, C, D).	—

Measure

Time frame

Mature Oocyte Count. Timepoint: Before intervention (prior to ovarian stimulation) and after intervention (oocyte retrieval). Method of measurement: Number of mature oocytes (count).;Fertilization Rate. Timepoint: After sperm injection into oocytes (ICSI) and follow-up until embryo culture. Method of measurement: Fertilization success rate (percentage).;Embryo Quality. Timepoint: After embryo culture in the laboratory (Day 3 or 5 after oocyte retrieval). Method of measurement: Embryo grading (Grade A, B, C, D).

—

Secondary

Measure	Time frame
Immature Oocyte Count (MI and GV). Timepoint: Before intervention and after intervention. Method of measurement: Percentage of immature oocytes (percentage).;Number of Grade A Embryos. Timepoint: After embryo culture in the laboratory. Method of measurement: Number of Grade A embryos (count).;Clinical Pregnancy Rate. Timepoint: After embryo transfer and confirmation of clinical pregnancy via ultrasound. Method of measurement: Clinical pregnancy rate (percentage).	—

Measure

Time frame

Immature Oocyte Count (MI and GV). Timepoint: Before intervention and after intervention. Method of measurement: Percentage of immature oocytes (percentage).;Number of Grade A Embryos. Timepoint: After embryo culture in the laboratory. Method of measurement: Number of Grade A embryos (count).;Clinical Pregnancy Rate. Timepoint: After embryo transfer and confirmation of clinical pregnancy via ultrasound. Method of measurement: Clinical pregnancy rate (percentage).

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactElham Naghshineh

Esfahan University of Medical Sciences

naghshineh@med.mui.ac.ir+98 31 3668 0048

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026