Infertility, FemaleNCT05755529
Effects of Low LH Serum Levels on Ovarian Pick-up Outcome
An observational study of Infertility, Female and ART, run by University of Palermo.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Infertility, Female, ART
- How many people
- 43 participants
- Where
- No sites listed yet
- Study dates
- Mar 2023to Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: Women who received ovarian stimulation with follitropin alfa (Gonal F, Merck Serono, Germany) and ganirelix (Fyremaldel, Sun Pharma, Italy).
Who may be able to join
- 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,
Who cannot join
- abnormal cervical cytology, affected by any other endocrinological, metabolic, autoimmune, and gynecological disease.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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).
- Conditions
- Infertility, Female, ART
- Keywords
- embryo quality, LH levels, Oocyte retrieval
- Medical subject headings
- Infertility, Female
What is being measured
The primary outcome is the main question the study is designed to answer.
Oocyte retrieval
number of retrieved oocytes after controlled ovarian stimulation
Measured: immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2023
- Study startMar 2023 (estimated)
- Primary completionMar 2023 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 43 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Palermo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Etrusco, University of Palermo
- Investigators
- Jessica Dragotto, Biologist, Principal investigator, Clinica del Mediterraneo - RagusaGiovanni Bracchitta, M.D., Study director, Clinica del Mediterraneo - RagusaAntonio Simone Laganà, M.D., Ph.D., Study chair, University of PalermoAndrea Etrusco, M.D., Study chair, University of Palermo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05755529
- Sponsor's protocol ID
- LH-OS-1
- Status last verified
- Mar 2023
- First submitted
- 8 Feb 2023
- Last updated
- 6 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Low LH Serum Levels on Oocyte Retrieval, Fertilization Rate and Embryo Quality During Controlled Ovarian Stimulation: Results From a Prospective Cohort Analysis
- ClinicalTrials.gov ID
- NCT05755529
- Acronym / sponsor ID
- LH-OS-1
- Conditions
- Infertility, Female, ART
- Keywords
- embryo quality, LH levels, Oocyte retrieval
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- University of PalermoUniversity, hospital or other
- Study start
- Mar 2023 (estimated)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 6 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women who received ovarian stimulation with follitropin alfa (Gonal F, Merck Serono, Germany) and ganirelix (Fyremaldel, Sun Pharma, Italy).
Key inclusion criteria (1 listed)
- 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,
Key exclusion criteria (1 listed)
- abnormal cervical cytology, affected by any other endocrinological, metabolic, autoimmune, and gynecological disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Oocyte retrieval
Time frame: immediately after the intervention
number of retrieved oocytes after controlled ovarian stimulation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessica Dragotto, Biologist principal investigator
Clinica del Mediterraneo - Ragusa
Giovanni Bracchitta, M.D. study director
Clinica del Mediterraneo - Ragusa
Antonio Simone Laganà, M.D., Ph.D. study chair
University of Palermo
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, Female and ART, run by University of Palermo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrea Etrusco, M.D. (+39 3881715032, etruscoandrea@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oocyte retrieval (time frame: immediately after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2023.