Cinnamon and COH in PCOS Women Underdoing IVF/ICSI Cycles

NCT06199024 | Recruiting DMC

• 2 other identifiers: 402000037IRCT20080831001141N44
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

In patients with polycystic ovary syndrome, insulin resistance increases, and since the extracts from cinnamon reduces insulin resistance by two mechanisms (1- increasing activation of the IRS/PI-3 kinase insulin signaling pathway and 2- stimulate auto phosphorylation of the insulin receptor and inhibit protein tyrosine phosphatase I). Through these two mechanisms cinnamon extract make adipocytes to increase the glucose uptake and glycogen synthesis. So this hypothesis arises that it can be effective in improving the symptoms of polycystic ovary syndrome.

Conditions

Polycystic Ovary Syndrome

Outcome Measures

Primary Outcomes (4)

• Total number of retrieved oocytes

  At the point of ovum pick-up, the total number of retrieved oocytes is counted by the embryologist. Therefore, it will be possible to measure the results one hour after oocytes retrieval.

  32-34 hours after hCG administration (approximately 6 weeks after intervention)

• Total number of mature (MII) oocytes

  At the point of ovum pick-up, the total number of retrieved oocytes is counted by the embryologist. Therefore, it will be possible to measure the results one hour after oocytes retrieval.

  32-34 hours after hCG administration (approximately 6 weeks after intervention)

• Oocyte recovery ratio

  This ratio is obtained by dividing the total number of retrieved oocytes by the total number of aspirated follicles from both ovaries.

  32-34 hours after hCG administration (approximately 6 weeks after intervention)

• Oocyte maturity rate

  This ratio is calculated by dividing the number of mature oocytes (MII) obtained by the total number of retrieved oocytes from both ovaries.

  32-34 hours after hCG administration (approximately 6 weeks after intervention)

Secondary Outcomes (2)

• Fertilization rate

  17-18 h after intracytoplasmic sperm injection and/or in-vitro insemination by checking the number of polar bodies and pronuclei

• Quality of obtained embryos

  3 days after intracytoplasmic sperm injection or in vitro fertilization (IVF/ICSI) procedure

Study Arms (2)

Cinnamon supplementation

EXPERIMENTAL

In intervention group patients will take 1500 mg daily (3 tablets of cinnamon 500 mg, Sagepad Darou Pharmaceutical Company, Iran) that is, 4 weeks before the start of the new IVF cycle and 2 weeks during the ovarian stimulation process.

Dietary Supplement: Oral cinnamon supplementation

Control group

PLACEBO COMPARATOR

Patients take 3 placebo pills daily (containing white wheat flour, which is similar to cinnamon pills in terms of size, shape, color and smell, Sagepad Darou Pharmaceutical Company, Iran) 4 weeks before starting the ovarian stimulation/in vitro fertilization (COS/IVF) cycle and 2 weeks during the ovarian stimulation procedure, the ovary will be stimulated

Dietary Supplement: Oral cinnamon supplementation

Interventions

Oral cinnamon supplementation DIETARY_SUPPLEMENT

In intervention group patients will take 1500 mg daily (3 tablets of cinnamon 500 mg, Sagepad Darou Pharmaceutical Company, Iran) that is, 4 weeks before the start of the new IVF cycle and 2 weeks during the ovarian stimulation process.

Cinnamon supplementation; Control group

Eligibility Criteria

• Age: 18 Years - 38 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Infertile women with polycystic ovary syndrome (PCOS) diagnosed according to the Rotterdam criteria who meet at least 2 of the following three criteria including: (1) oligomenorrhea or anovulation, (2) hyperandrogenism (clinical or biochemical ng/ dL 80 ≤ serum T level), (3) the presence of polycystic ovaries in ultrasound).
• The age range of 18 to 38 year.
• Written consent to participate in the study

You may not qualify if:

• Body mass index above 35 kg/m2
• Chronic and Endocrine disorders including diabetes mellitus, hyperprolactinemia, hypertension, Cushing's syndrome
• Autoimmune disorders
• History of recurrent pregnancy loss
• Genital, ovarian or uterine abnormalities
• Hydrosalpinx diagnosis
• Congenital adrenal hyperplasia, androgen-producing tumors or acromegaly
• Sensitivity to cinnamon
• Daily and frequent consumption of cinnamon to treat infertility
• Severe male factor infertility
• Moderate to severe endometriosis diagnosis Use of other hypoglycemic, insulin-sensitizing drugs (e.g. Metformin) or other antioxidant supplement (e.g. Myo-inositol) and β-blocker before or during the study

Sponsors & Collaborators

• Royan Institute: lead

Study Sites (1)

Royan Institute

Tehran, 1665659911, Iran

RECRUITING

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Study Officials

• Parvaneh Afsharian, Ph.D

  Royan Institute

  STUDY CHAIR

• Zeynab Siahnouri, Doctor

  Royan Institute

  STUDY DIRECTOR

Central Study Contacts

Maryam Hafezi, M.D

CONTACT

+98 21 2356 2000; maryamhafezi90@gmail.com

Parvaneh Afsharian, Ph.D

CONTACT

+98 21 2356 2000; p.afsharian@royan-rc.ac.ir

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2023
• First Posted: January 10, 2024
• Study Start: November 21, 2023
• Primary Completion: November 21, 2025
• Study Completion: February 21, 2026
• Last Updated: January 10, 2024

Record last verified: 2023-12

Locations

IR (1)