- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05755529
Effects of Low LH Serum Levels on Ovarian Pick-up Outcome
March 3, 2023 updated by: Andrea Etrusco, University of Palermo
Effects of Low LH Serum Levels on Oocyte Retrieval, Fertilization Rate and Embryo Quality During Controlled Ovarian Stimulation: Results From a Prospective Cohort Analysis
Luteinizing hormone (LH) plays a key role for normal follicular development and oocyte maturation in controlled ovarian stimulation.
In particular, LH stimulates the proliferation and differentiation of theca cells for the secretion of androgens, which synergistically increase the production of estrogen.
This study aimed to investigate the effects of low LH concentrations on oocyte retrieval, fertilization and embryo development in patients undergoing in vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI).
Patients undergoing IVF/ICSI were prospectively analyzed, subdividing them into three groups according to their age.
Serum LH levels were evaluated at day 3, during stimulation (day 10) and before ovulation induction (day 12).
Study Overview
Status
Not yet recruiting
Conditions
Study Type
Observational
Enrollment (Anticipated)
43
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Andrea Etrusco, M.D.
- Phone Number: +39 3881715032
- Email: etruscoandrea@gmail.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Women who received ovarian stimulation with follitropin alfa (Gonal F, Merck Serono, Germany) and ganirelix (Fyremaldel, Sun Pharma, Italy).
Description
Inclusion Criteria:
age between 18 and 40 years, body mass index 18-29 kg/m 2 , regular menstrual cycles, normal uterine cavity assess by hysteroscopy, normal uterus and ovaries at transvaginal sonography,
Exclusion Criteria:
abnormal cervical cytology, affected by any other endocrinological, metabolic, autoimmune, and gynecological disease.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Oocyte retrieval
Time Frame: immediately after the intervention
|
number of retrieved oocytes after controlled ovarian stimulation
|
immediately after the intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Antonio Simone Laganà, M.D., Ph.D., University of Palermo
- Principal Investigator: Jessica Dragotto, Biologist, Clinica del Mediterraneo - Ragusa
- Study Director: Giovanni Bracchitta, M.D., Clinica del Mediterraneo - Ragusa
- Study Chair: Andrea Etrusco, M.D., University of Palermo
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
March 1, 2023
Primary Completion (Anticipated)
March 1, 2023
Study Completion (Anticipated)
March 1, 2023
Study Registration Dates
First Submitted
February 8, 2023
First Submitted That Met QC Criteria
March 3, 2023
First Posted (Estimate)
March 6, 2023
Study Record Updates
Last Update Posted (Estimate)
March 6, 2023
Last Update Submitted That Met QC Criteria
March 3, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- LH-OS-1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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