NCT01659788

Brief Summary

The goal of the investigators research is to explore energy production of the ovarian follicle in older reproductive age women at the time of oocyte retrieval.

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
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2012

Typical duration for not_applicable

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

August 5, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 8, 2012

Completed
24 days until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

August 8, 2012

Status Verified

August 1, 2012

Enrollment Period

2 years

First QC Date

August 5, 2012

Last Update Submit

August 7, 2012

Conditions

Ovarian Function at Advanced Reproductive Age

Keywords

Advanced Reproductive Agepoor ovarian responseMitochondrial dysfunctionMitochondrial nutrientsCoenzyme Q10Electron transfer chain

Outcome Measures

Primary Outcomes (2)

  • level of ATP production

    2 years

  • Steriodogenesis associated enzymatic activity

    2 years

Secondary Outcomes (4)

  • Ovarian Response

    2 years

  • Embryo quality

    2 years

  • cumulative pregnancy rate per retrieval

    2 years

  • cumulative live birth rate per retrieval

    2 years

Other Outcomes (1)

  • Co Enzyme Q10 levels in maternal serum by HPLC

    2 years

Study Arms (2)

Coenzyme Q10 concomitant treatment

EXPERIMENTAL

Coenzyme Q10 concomitant treatment to fertility drugs as part of an IVF treatment Dose: 600 mg by mouth daily beginning 3 months prior to IVF cycle. Patient will stop taking the CoEnzyme Q10 if conceives or when the study is completed. Other name: Ubiquinone

Dietary Supplement: Coenzyme Q10 concomitant treatment

Placebo

PLACEBO COMPARATOR

1 capsule by mouth daily beginning 3 months prior to IVF cycle. Patient will stop taking the placebo when she conceives or when the study is completed.

Dietary Supplement: Placebo

Interventions

Coenzyme Q10 concomitant treatmentDIETARY_SUPPLEMENT
Coenzyme Q10 concomitant treatment
PlaceboDIETARY_SUPPLEMENT
Placebo

Eligibility Criteria

Age38 Years - 43 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 38-43 years at the time of enrollment
  • Diagnosis of primary infertility

You may not qualify if:

  • Body mass index (BMI) \> 30 kg/m2
  • Early follicular phase (day 2-4) serum FSH level \> 20 mIU/ml.
  • Abnormal uterine cavity as evidenced by sonohysterogram or hysterosalpingography
  • Any current use of systemic steroid medication or any infertility treatment within 3 months of study enrollment.
  • Any contraindication to being pregnant and carrying a pregnancy to term.
  • Contraindication for the use of CoQ10, or fertility medications.
  • Any ovarian or abdominal abnormality that may interfere with adequate TVS evaluation.
  • Absence of one or two ovaries
  • Clinically relevant systemic disease (e.g., Insulin-dependent diabetes, adrenal dysfunction, organic intracranial lesion, polycystic ovarian syndrome, hyperprolactinemia, or hypothalamic tumor) or serious illness (Neoplasia).
  • History (within past 12 months) or current abuse of alcohol or drugs.
  • Administration of any investigational drugs within three months prior to study enrollment.
  • Any medical condition that may interfere with the absorption, distribution, metabolism or excretion of the study drugs, gastrointestinal diseases, mal absorption syndromes and liver dysfunction
  • Unexplained gynecological bleeding.
  • Ejaculated sperm is not sufficient for ICSI
  • Patient not able to communicate adequately with the investigators and to comply with the requirements of the entire study.
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Organization

Jerusalem, Israel

Location

MeSH Terms

Conditions

Mitochondrial Diseases

Condition Hierarchy (Ancestors)

Metabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Ronit Kochman, MD

    Hadassah Medical Organization

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ronit Kochman, MD

CONTACT

00 972 50 8946414kochman@hadassah.org.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2012

First Posted

August 8, 2012

Study Start

September 1, 2012

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

August 8, 2012

Record last verified: 2012-08

Locations

IL(1)