Effect of Fasting on ICSI Outcomes in Poor Responders

NCT03714009 | Completed

• 1 other identifier: 88766808
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a prospective, randomized controlled trial conducted at the In Vitro Fertilization ( IVF) center of the Department of Obstetrics \& Gynecology, Kasr El-Ainy Teaching Hospital, Faculty of Medicine, Cairo University, Egypt, from October 2018 to September 2019, to determine the clinical effect of fasting on ICSI outcomes in poor responders 360 participants will be randomized withdrawing closed envelopes for each patient into group A and group B . Group (A): patients will have periodic fasting for 4 weeks prior to the treatment cycle. The fasting method involves daily fasts of 14-16hours and restrict eating to an 8-10 hour "eating window" as 2-3 or more meals of balanced diet. Group (B): no fasting, patients will have usual balanced diet as 3 meals and 2 snacks all over the day. Both groups should take adequate water and non calorie beverages intake daily (2-3 liters). All patients will start the ICSI cycle using the same treatment protocol. Primary outcome is clinical pregnancy rate per cycle. Secondary outcomes include Body mass index (BMI) and waist/hip ratio (WHR), fasting insulin , fasting plasma glucose, Homeostatic model assessment (HOMA) index, lipid profile ( Triglycerides (TGs), total cholesterol, High density Lipoprotein (HDL), Low density Lipoprotein (LDL), AntiMullerian Hormone (AMH), Basal Follicle Stimulating Hormone (FSH), Luteinizing Hormone (LH), Estradiol (E2, Days of stimulation , dose of gonadotrophins, number of M II oocytes retrieved, number of grade1and 2 embryos, number of frozen embryos, freeze all cycles, Ovarian Hyperstimulation syndrome (OHSS), Chemical pregnancy rate, clinical pregnancy, twins, abortion, ectopic pregnancy, preterm labour, live birth rate

Conditions

Infertility

Keywords

Infertility; Poor ovarian reserve; Intracytoplasmic sperm injection; fasting

Outcome Measures

Primary Outcomes (1)

• clinical pregnancy rate per cycle

  detection of gestationalsac, embryonal pole and fetal pulsations by ultrasonography

  10 weeks

Secondary Outcomes (15)

• Body mass index

  4 weeks of fasting

• Waist/Hip ratio

  4 weeks of fasting

• Number of days of stimulation with gonadotrophins

  6 weeks

• Number of ampoules of gonadotrophins

  6 weeks

• number of M II oocytes retrieved

  6 weeks

Study Arms (2)

Fasting group

ACTIVE COMPARATOR

Patients will have periodic fasting for 4 weeks prior to the treatment cycle. The fasting method involves daily fasts of 14-16hours and restrict eating to an 8-10 hour "eating window" as 2-3 or more meals of balanced diet. They should take adequate water and non calorie beverages intake daily (2-3 liters)

Behavioral: Fasting

Non fasting group

OTHER

no fasting, patients will have usual balanced diet as 3 meals and 2 snacks all over the day. They should take adequate water and non calorie beverages intake daily (2-3 liters)

Behavioral: No fasting

Interventions

Fasting BEHAVIORAL

Periodic fasting last for 4weeks prior to the treatment cycle. The fasting method involves daily fasts of 14-16hours and restrict eating to an 8-10 hour "eating window" as 2-3 or more meals of balanced diet. Patients should take adequate water and non calorie beverages intake daily (2-3 liters).

Also known as: Periodic fasting

Fasting group

No fasting BEHAVIORAL

Patients will not fast . But they will take balanced food and drink 2 to 3 liters of water and non caloric drinks all the day for 4 weeks

Non fasting group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

The study will include: infertile patients with poor ovarian reserve (POR )diagnosed by low Antral follicle count (AFC)( less than 5 follicles), Elevated basal follicle-stimulating hormone (FSH) (more than 10 IU/mL) and low anti-Mullerian hormone (AMH)(less than 1.5 ng/ml), previous POR (≤three oocytes with a conventional stimulation protocol). Women with diabetes, thyroid disorder or other endocrine dysfunctions, uterine abnormalities were excluded.Also severe oligo-astheno-teratozoospermia or azospermia are excluded.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

KasrELAiniH

Cairo, 11956, Egypt

Location

MeSH Terms

Conditions

Infertility; Fasting

Interventions

Angptl4 protein, mouse

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Feeding Behavior; Behavior

Study Officials

• Amira S Dieb, MD

  KasrAlainiH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Amira S Dieb, MD

Study Record Dates

• First Submitted: September 26, 2018
• First Posted: October 22, 2018
• Study Start: October 31, 2018
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: September 9, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)