NCT01892111

Brief Summary

Obese women experience increased infertility rate and longer time to conception showing lower pregnancy and live-birth rates both in natural and assisted conceptions. Body weight loss improves not only spontaneous pregnancy rates but also those of assisted reproductive techniques (ARTs). Almost all studies refer to body weight loss due to lifestyle intervention programs consisting in hypocaloric diet and increased physical activity, whereas very little is known about the specific effects of physical activity alone on human reproduction. In a previous retrospective study, we demonstrated that physical activity enhances the reproductive performance of obese infertile patients who receive in vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI) cycles, regardless of body weight loss. The aim of this randomized controlled trial (RCT) will be to evaluate if a structured exercise program improve the effectiveness of ARTs.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Oct 2013

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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

June 28, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 3, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

July 3, 2013

Status Verified

June 1, 2013

Enrollment Period

7 months

First QC Date

June 28, 2013

Last Update Submit

June 28, 2013

Conditions

InfertilityObesityStable BMI

Keywords

SETinfertilityIVF/ICSIpregnancy

Outcome Measures

Primary Outcomes (1)

  • pregnancy rate.

    4 months

Secondary Outcomes (7)

  • stimulation lenght and dose

    1 month

  • cancellation rate

    1 months

  • implantation rate

    1 month

  • OHSS rate

    1 month

  • embryo transferred

    1 month

  • +2 more secondary outcomes

Study Arms (2)

structured exercise program (SET)

EXPERIMENTAL

SET one month before and during ARTs. IVF/ICSI procedure.

Other: Structured exercise program.

no intervention

NO INTERVENTION

IVF/ICSI procedure.

Interventions

Structured exercise program.OTHER
structured exercise program (SET)

Eligibility Criteria

Age18 Years - 42 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • infertility
  • obesity
  • stable BMI
  • schedule for ARTs

You may not qualify if:

  • use of cryopreserved embryos
  • any changes in diet and physical activity
  • tobacco smoking
  • drug use
  • alcohol abuse
  • uterine diseases
  • previous pelvic surgery
  • major medical diseases
  • clinical history of (or suspicion of) endometriosis, antiphospholipid antibody syndrome, recurrent miscarriage
  • obese partner
  • severe sperm pathology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unit of Gynecology & Obstetrics - Arcispedale S. Maria Nuova of Reggio Emilia, IRCCS, University of Modena and Reggio Emilia

Reggio Emilia, 42123, Italy

Location

Related Publications (2)

  • Palomba S, Falbo A, Giallauria F, Russo T, Rocca M, Tolino A, Zullo F, Orio F. Six weeks of structured exercise training and hypocaloric diet increases the probability of ovulation after clomiphene citrate in overweight and obese patients with polycystic ovary syndrome: a randomized controlled trial. Hum Reprod. 2010 Nov;25(11):2783-91. doi: 10.1093/humrep/deq254. Epub 2010 Sep 21.

    PMID: 20858697BACKGROUND

  • Palomba S, Giallauria F, Falbo A, Russo T, Oppedisano R, Tolino A, Colao A, Vigorito C, Zullo F, Orio F. Structured exercise training programme versus hypocaloric hyperproteic diet in obese polycystic ovary syndrome patients with anovulatory infertility: a 24-week pilot study. Hum Reprod. 2008 Mar;23(3):642-50. doi: 10.1093/humrep/dem391. Epub 2007 Dec 23.

    PMID: 18158291BACKGROUND

MeSH Terms

Conditions

InfertilityObesity

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Stefano Palomba, MD

CONTACT

stefanopalomba@tin.it

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 28, 2013

First Posted

July 3, 2013

Study Start

October 1, 2013

Primary Completion

May 1, 2014

Study Completion

June 1, 2014

Last Updated

July 3, 2013

Record last verified: 2013-06

Locations

IT(1)