Premature Ovarian FailureNCT03412487
Ovarian Histopathology and Laparoscopic Assessment of Premature Ovarian Failure
A study testing laparoscopy in people with Premature Ovarian Failure, run by Cairo University at 1 site in Egypt.
Trial summary
25 women with Premature Ovarian Failure who attended Fayoum university hospital gynecology outpatient clinic (case group) and another group of 25 women with normal ovarian function (control group). Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Premature Ovarian Failure
- What is being tested?
- laparoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2018to Jan 2019
- Phase
- Interventional
- 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Woman under age of 40y.
- Infertility.
- History of oligomenorrhea or amenorrhea for 1 year or more FSH level >20 IU/L at least 2 occasions 4-6 weeks apart (FSH level 20-40 IU/L indicates ovarian insufficiency, while level above 40 IU/L indicates complete failure).
- History of thyroid dysfunction, postpartum thyroiditis and or thyroid surgery.
- Symptoms or signs suggestive of thyroid dysfunction or goiter.
- Family history of thyroid dysfunction or goiter.
Show all 9Show fewer
- Presence of thyroid antibodies or other antibodies.
- Type 1 Diabetes Mellitus.
- Prior irradiation to head and neck
Who cannot join
- Women above 40 yrs.
- Follicle stimulating hormone (FSH) less than 20mIU/mL
- Women using hormonal treatement, exposed to radiation to abdomen or pelvis, chemotherapy, or ovarian surgery.
Trial locations and contacts
1 site in 1 country.
Sahar Elbaradiee, MD contact
About this study
Official title: Ovarian Histopathology and Laparoscopic Assessment of Premature Ovarian Failure and Its Relation to Thyroid Dysfunction
25 women with Premature Ovarian Failure who attended Fayoum university hospital gynecology outpatient clinic (case group) and another group of 25 women with normal ovarian function (control group).
*Pelvic laparoscopy and ovarian biopsy will be done ovarian biopsy preparation
For assessment of autoimmune oophoritis, sections were immunostained with anti-LCA (CD45) monoclonal antibody
Read the detailed description
25 women with Premature Ovarian Failure who attended Fayoum university hospital gynecology outpatient clinic (case group) and another group of 25 women with normal ovarian function (control group).Pelvic laparoscopy and ovarian biopsy To be examined histologically. All procedures were performed under general anesthesia the utero-ovarian ligament was stabilized with the round biopter introduced through the other. The round metal biopter 5 mm in diameter with an inner protective trocar.
The tip of the biopsy instrument was placed on an area of the ovary free of cysts; the hilar area was avoided because it is deficient in small follicles. After correct placement was verified, the inner protecting trocar was removed to expose the sharp leading edge of the round sheath. Gentle circular movements were made cutting through the ovarian cortex to produce a 5-mm disk of 2-3 mm in thickness. The round biopter was removed, and a grasper was introduced to recover the excised tissue.
Ovarian biopsy specimens were fixed in 10% formalin and embedded in paraffin forming tissue blocks. Two sections, 4μ thick were cut from each block. One was stained with routine haematoxylin and eosin (H\&E) stain while the other was immunostained with anti-Leukocyte Common Antigen (LCA).
For assessment of autoimmune oophoritis, sections were immunostained with anti-LCA (CD45) monoclonal antibody
- Conditions
- Premature Ovarian Failure
- Being tested
- laparoscopy
- Medical subject headings
- Primary Ovarian Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopyProcedure or surgery
under general anesthesia. CO2 pneumoperitoneum, the laparoscope inserted through the umbilicus and a thorough evaluation of the abdominal cavity and pelvis was performed. a grasper was inserted; the utero-ovarian ligament was stabilized with the round biopter will be introduced. The tip of the biopsy instrument was placed on an area of the ovary free of cysts; the hilar area was avoided because it is deficient in small follicles. After correct placement was verified, the inner protecting trocar was removed to expose the sharp leading edge of the round sheath. Gentle circular movements were made cutting through the ovarian cortex to produce a 5-mm disk of 2-3 mm in thickness.
| Study group | Role | What they receive |
|---|---|---|
| premature ovarian failure | Active comparator | women under 40 years old with History of oligomenorrhea or amenorrhea for 1 year or more FSH level >20 IU/L at least 2 occasions 4-6 weeks apart (FSH level 20-40 IU/L indicates ovarian insufficiency, while level above 40 IU/L indicates complete failure). Receives: Procedure: laparoscopy |
| Control group | Active comparator | A group of female patients presented with infertility but with regular menses and normal ovarian function (according to history, general examination, gynecological examination and FSH level). Receives: Procedure: laparoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
presence of autoimuune oophoritis
Autoimmune oophritis was assessed by quantifying LCA positive cells in ovarian stroma as follows:
[Type text] 0= not convincing.
- mild autoimmune oophritis.
- moderate autoimmune oophritis.
- sever autoimmune oophritis.
Measured: at time of laproscopy procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2018
- Study startJan 2018 (estimated)
- Primary completionDec 2018 (estimated)
- Study completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature Ovarian FailureStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Maged, Cairo University
- Investigators
- Ahmed Maged, MD, Principal investigator, professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03412487
- Sponsor's protocol ID
- 21
- Status last verified
- Jan 2018
- First submitted
- 21 Jan 2018
- Last updated
- 26 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ovarian Histopathology and Laparoscopic Assessment of Premature Ovarian Failure and Its Relation to Thyroid Dysfunction
- ClinicalTrials.gov ID
- NCT03412487
- Acronym / sponsor ID
- 21
- Conditions
- Premature Ovarian Failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jan 2018 (estimated)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 26 Jan 2018 (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.
25 women with Premature Ovarian Failure who attended Fayoum university hospital gynecology outpatient clinic (case group) and another group of 25 women with normal ovarian function (control group).
*Pelvic laparoscopy and ovarian biopsy will be done ovarian biopsy preparation
For assessment of autoimmune oophoritis, sections were immunostained with anti-LCA (CD45) monoclonal antibody
Detailed description
25 women with Premature Ovarian Failure who attended Fayoum university hospital gynecology outpatient clinic (case group) and another group of 25 women with normal ovarian function (control group).Pelvic laparoscopy and ovarian biopsy To be examined histologically. All procedures were performed under general anesthesia the utero-ovarian ligament was stabilized with the round biopter introduced through the other. The round metal biopter 5 mm in diameter with an inner protective trocar.
The tip of the biopsy instrument was placed on an area of the ovary free of cysts; the hilar area was avoided because it is deficient in small follicles. After correct placement was verified, the inner protecting trocar was removed to expose the sharp leading edge of the round sheath. Gentle circular movements were made cutting through the ovarian cortex to produce a 5-mm disk of 2-3 mm in thickness. The round biopter was removed, and a grasper was introduced to recover the excised tissue.
Ovarian biopsy specimens were fixed in 10% formalin and embedded in paraffin forming tissue blocks. Two sections, 4μ thick were cut from each block. One was stained with routine haematoxylin and eosin (H\&E) stain while the other was immunostained with anti-Leukocyte Common Antigen (LCA).
For assessment of autoimmune oophoritis, sections were immunostained with anti-LCA (CD45) monoclonal antibody
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| premature ovarian failure | Active comparator | Procedure: laparoscopywomen under 40 years old with History of oligomenorrhea or amenorrhea for 1 year or more FSH level >20 IU/L at least 2 occasions 4-6 weeks apart (FSH level 20-40 IU/L indicates ovarian insufficiency, while level above 40 IU/L indicates complete failure). |
| Control group | Active comparator | Procedure: laparoscopyA group of female patients presented with infertility but with regular menses and normal ovarian function (according to history, general examination, gynecological examination and FSH level). |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Woman under age of 40y.
Key exclusion criteria (3 listed)
- Women above 40 yrs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| laparoscopyunder general anesthesia. CO2 pneumoperitoneum, the laparoscope inserted through the umbilicus and a thorough evaluation of the abdominal cavity and pelvis was performed. a grasper was inserted; the utero-ovarian ligament was stabilized with the round biopter will be introduced. The tip of the biopsy instrument was placed on an area of the ovary free of cysts; the hilar area was avoided because it is deficient in small follicles. After correct placement was verified, the inner protecting trocar was removed to expose the sharp leading edge of the round sheath. Gentle circular movements were made cutting through the ovarian cortex to produce a 5-mm disk of 2-3 mm in thickness. | Procedure or surgery | Control group, premature ovarian failure |
Primary outcome
presence of autoimuune oophoritis
Time frame: at time of laproscopy procedure
Autoimmune oophritis was assessed by quantifying LCA positive cells in ovarian stroma as follows: [Type text] 0= not convincing. 1. mild autoimmune oophritis. 2. moderate autoimmune oophritis. 3. sever autoimmune oophritis.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Premature Ovarian Failure
RecruitingPhase 2
Autologous Hair Follicle-Derived Secretome and Platelet-Rich Plasma for Premature Ovarian Insufficiency
Premature Ovarian Insufficiency, POI
RecruitingObservational study
Gonadal Tissue Freezing for Fertility Preservation in Individuals at Risk for Ovarian Dysfunction, Premature Ovarian Insufficiency and Clinically Indicated Gonadectomy
Turner Syndrome, Post-menarcheal Adolescents
Not yet recruitingPhase 1
Oral GDC-0077 in Premature Ovarian Insufficiency
Primary Ovarian Insufficiency
RecruitingPhase 3
Hormone Replacement Therapy in Adolescents With Premature Ovarian Insufficiency
Premature Ovarian Insufficiency
RecruitingObservational study
Gonadotropin-releasing Hormone Agonist (GnRHa) in Ovarian Preservation in SLE Subjects Receiving Cyclophosphamide as Determined by Questionnaires
Systemic Lupus Erythematosus (Sle), Primary Ovarian Insufficiency (Poi)
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.
Sahar Elbaradiee, MD contact
Ahmed Maged, MD principal investigator
professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laparoscopy in people with Premature Ovarian Failure, run by Cairo University at 1 site in Egypt.
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 9 inclusion and 3 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 26 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Ahmed Maged, MD (+2001005227404, prof.ahmedmaged@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
presence of autoimuune oophoritis (time frame: at time of laproscopy procedure). 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 26 Jan 2018.