NCT04275869

Brief Summary

Obesity and overweight are among the problems that produce infertility. The combination of diet and exercise to achieve weight loss are currently considered an effective intervention for the improvement of reproductive parameters in overweight or obese infertile women. Aim: to evaluate the effectiveness of an online program to promote a healthy lifestyle among women who are overweight or obese who also have a diagnosis of infertility and are on the waiting list for in vitro fertilisation treatment

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2020

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 17, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 19, 2020

Completed
8 days until next milestone

Study Start

First participant enrolled

February 27, 2020

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2024

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2024

Completed
Last Updated

February 12, 2025

Status Verified

February 1, 2025

Enrollment Period

4.1 years

First QC Date

February 17, 2020

Last Update Submit

February 10, 2025

Conditions

ObesityInfertility, Female

Keywords

infertilityobesityphysical activitynutritioninternet

Outcome Measures

Primary Outcomes (1)

  • Spontaneous clinical pregnancy rate

    The primary outcome will be the spontaneous clinical pregnancy rate (pregnancy with ultrasound visualisation of the gestational sac at week 7 of pregnancy) and evolution (pregnancy with ultrasound visualisation of the gestational sac and a heartbeat after 20 weeks of gestation).

    12 months

Secondary Outcomes (4)

  • Body mass index (BMI)

    12 months

  • Abdominal perimeter

    12 months

  • Mediterranean Diet Adherence

    12 months

  • Physical activity level

    12 months

Study Arms (2)

Experimental Healthy Lifestyle

EXPERIMENTAL

A 3-month internet-based program focusing on the promotion of healthy lifestyles. The treatment protocol comprises 9 modules which incorporate psychological strategies to promote healthy lifestyles by gradually changing eating and physical activity habits.

Other: Healthy Lifestyle

Control Group

NO INTERVENTION

Control group will receive the standard treatment which consists of regular gynaecological visits; the Reproduction Service gynaecologists will recommend healthy lifestyle habits and give the patients a document detailing a specific diet they should follow for weight loss.

Interventions

Healthy LifestyleOTHER

A 3-month internet-based program focusing on the promotion of healthy lifestyles. The treatment protocol comprises 9 modules which incorporate psychological strategies to promote healthy lifestyles by gradually changing eating and physical activity habits.

Experimental Healthy Lifestyle

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • women of childbearing age
  • overweight (BMI \> 25 kg/m2) or obese (BMI \> 30 kg/m2)
  • diagnosed with primary infertility -access to the internet-

You may not qualify if:

  • over 40 years
  • morbid or extreme obesity (BMI \> 40 kg/m2)
  • bilateral obstruction of the fallopian tubes
  • endometriosis
  • women whose partner has a severe male factor (oligoasthenoteratozoospermia).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital La Plana de Villarreal

Castellon, Castellón, Spain

Location

MeSH Terms

Conditions

ObesityInfertility, FemaleInfertilityMotor Activity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesBehavior

Study Officials

  • JUAN FRANCISCO L PÁRRAGA, PhD

    Cardenal Herrera University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Medicine

Study Record Dates

First Submitted

February 17, 2020

First Posted

February 19, 2020

Study Start

February 27, 2020

Primary Completion

April 15, 2024

Study Completion

April 30, 2024

Last Updated

February 12, 2025

Record last verified: 2025-02

Locations

ES(1)