Fibroid UterusNCT03904368
The Value of Myomectomy in Women With Intramural Myoma Before IVF.
A study testing Open myomectomy, Gonadotropins and Human chorionic gonadotropin in people with Fibroid Uterus and IVF, run by Cairo University at 1 site in Egypt.
Trial summary
Women with intramural myoma not reaching the endometrial cavity will be randomized to either open myomectomy or no intervention . The participants will be assessed through full history-taking with special consideration to age and the duration, type, and cause of infertility. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Fibroid Uterus, IVF
- What is being tested?
- Open myomectomy, Gonadotropins and Human chorionic gonadotropin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- Apr 2019to Dec 2020
- 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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- • age younger than 40 years
- FSH) less than 10 IU/L
- serum prolactin level normal
- uterine cavity abnormality was excluded by hysteroscopy or hysterosalpingography
Who cannot join
- abnormal endocrine function (e.g. abnormal thyroid or adrenal function)
- ovarian cysts,
- hydrosalpinx
- endometrial polyps
- male partner with azoospermia
- ICSI performed for preimplantation genetic diagnosis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Value of Myomectomy in Women With Intramural Myoma Before IVF. A Randomized Controlled Trial
Women with intramural myoma not reaching the endometrial cavity will be randomized to either open myomectomy or no intervention . The participants will be assessed through full history-taking with special consideration to age and the duration, type, and cause of infertility. The medical examination included general, abdominal, and vaginal examinations. Finally, an ultrasonography examination was performed to check for the presence of three or more preantral follicles and to exclude ovarian cysts. On day 3 of a natural cycle, a baseline levels of FSH, luteinizing hormone (LH),
, estradiol and anti-Müllerian hormone (AMH).Ovarian stimulation was performed using a long, antagonist, or short protocol. They were assigned to one of the 2 groups according to having an intramural myoma not indenting the cavity or not. All will be followed up by transvaginal ultrasonography . When two or more follicles had reached a mean diameter of 18 mm, oocyte maturation was triggered by intramuscular administration of hCG. Embryo transfer will be done at day 2, 3 or 5 according to the circumstances.
Read the detailed description
Women with intramural myoma not reaching the endometrial cavity will be randomized to either open myomectomy or no intervention .The participants will be assessed through full history-taking with special consideration to age and the duration, type, and cause of infertility. The medical examination included general, abdominal, and vaginal examinations. Finally, an ultrasonography examination was performed to check for the presence of three or more preantral follicles and to exclude ovarian cysts. On day 3 of a natural cycle, a baseline levels of FSH, luteinizing hormone (LH),
, estradiol and anti-Müllerian hormone (AMH).Ovarian stimulation was performed using a long, antagonist, or short protocol. They were assigned to one of the 2 groups according to having an intramural myoma not indenting the cavity or not. All will be followed up by transvaginal ultrasonography . When two or more follicles had reached a mean diameter of 18 mm, oocyte maturation was triggered by intramuscular administration of hCG. Embryo transfer will be done at day 2, 3 or 5 according to the circumstances.
- Conditions
- Fibroid Uterus, IVF
- Being tested
- Open myomectomy, Gonadotropins, Human chorionic gonadotropin, Ovum pick up, Embryo transfer
- Medical subject headings
- Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open myomectomyProcedure or surgery
laparotomy then enucleation of the myoma followed by closure of the myometrial cavity
GonadotropinsDrug
Also called Controlled Ovarian stimulation
Gonadotropin stimulation of follicular growth
Human chorionic gonadotropinDrug
Also called Ovulation triggering
HCG triggering of ovulation
Ovum pick upProcedure or surgery
34 to 36 hours after HCG triggering
Embryo transferProcedure or surgery
Transfer of 2 grade 1 embryo on day 2,3 or 5 from oocyte retrieval
| Study group | Role | What they receive |
|---|---|---|
| Myomectomy group | Active comparator | women with intramural myoma not reaching endometrial cavity will undergo open myomectomy followed by ovarian stimulation for in vitro fertilization 6 months after the operation Receives: Procedure: Open myomectomy; Drug: Gonadotropins; Drug: Human chorionic gonadotropin; Procedure: Ovum pick up; Procedure: Embryo transfer |
| Conservative group | Active comparator | women with intramural myoma not reaching endometrial cavity will undergo ovarian stimulation for in vitro fertilization Receives: Drug: Gonadotropins; Drug: Human chorionic gonadotropin; Procedure: Ovum pick up; Procedure: Embryo transfer |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical pregnancy rate
appearance of one or more intrauterine gestational sac by transvaginal ultrasound
Measured: 4 weeks after embryo transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2019
- Study startApr 2019 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibroid UterusStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed M Maged, MD, Cairo University
- Investigators
- Ahmed Maged, MD, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03904368
- Sponsor's protocol ID
- 55
- Status last verified
- Apr 2019
- First submitted
- 31 Mar 2019
- Last updated
- 5 Apr 2019
- 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 5 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value of Myomectomy in Women With Intramural Myoma Before IVF. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03904368
- Acronym / sponsor ID
- 55
- Conditions
- Fibroid Uterus, IVF
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Apr 2019 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 5 Apr 2019 (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.
Women with intramural myoma not reaching the endometrial cavity will be randomized to either open myomectomy or no intervention . The participants will be assessed through full history-taking with special consideration to age and the duration, type, and cause of infertility. The medical examination included general, abdominal, and vaginal examinations. Finally, an ultrasonography examination was performed to check for the presence of three or more preantral follicles and to exclude ovarian cysts. On day 3 of a natural cycle, a baseline levels of FSH, luteinizing hormone (LH),
, estradiol and anti-Müllerian hormone (AMH).Ovarian stimulation was performed using a long, antagonist, or short protocol. They were assigned to one of the 2 groups according to having an intramural myoma not indenting the cavity or not. All will be followed up by transvaginal ultrasonography . When two or more follicles had reached a mean diameter of 18 mm, oocyte maturation was triggered by intramuscular administration of hCG. Embryo transfer will be done at day 2, 3 or 5 according to the circumstances.
Detailed description
Women with intramural myoma not reaching the endometrial cavity will be randomized to either open myomectomy or no intervention .The participants will be assessed through full history-taking with special consideration to age and the duration, type, and cause of infertility. The medical examination included general, abdominal, and vaginal examinations. Finally, an ultrasonography examination was performed to check for the presence of three or more preantral follicles and to exclude ovarian cysts. On day 3 of a natural cycle, a baseline levels of FSH, luteinizing hormone (LH),
, estradiol and anti-Müllerian hormone (AMH).Ovarian stimulation was performed using a long, antagonist, or short protocol. They were assigned to one of the 2 groups according to having an intramural myoma not indenting the cavity or not. All will be followed up by transvaginal ultrasonography . When two or more follicles had reached a mean diameter of 18 mm, oocyte maturation was triggered by intramuscular administration of hCG. Embryo transfer will be done at day 2, 3 or 5 according to the circumstances.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Myomectomy group | Active comparator | Procedure: Open myomectomy, Drug: Gonadotropins, Drug: Human chorionic gonadotropin, Procedure: Ovum pick up, Procedure: Embryo transferwomen with intramural myoma not reaching endometrial cavity will undergo open myomectomy followed by ovarian stimulation for in vitro fertilization 6 months after the operation |
| Conservative group | Active comparator | Drug: Gonadotropins, Drug: Human chorionic gonadotropin, Procedure: Ovum pick up, Procedure: Embryo transferwomen with intramural myoma not reaching endometrial cavity will undergo ovarian stimulation for in vitro fertilization |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- • age younger than 40 years
Key exclusion criteria (6 listed)
- abnormal endocrine function (e.g. abnormal thyroid or adrenal function)
- ovarian cysts,
- hydrosalpinx
- endometrial polyps
- male partner with azoospermia
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 |
|---|---|---|
| Open myomectomylaparotomy then enucleation of the myoma followed by closure of the myometrial cavity | Procedure or surgery | Myomectomy group |
| GonadotropinsAlso: Controlled Ovarian stimulationGonadotropin stimulation of follicular growth | Drug | Conservative group, Myomectomy group |
| Human chorionic gonadotropinAlso: Ovulation triggeringHCG triggering of ovulation | Drug | Conservative group, Myomectomy group |
| Ovum pick up34 to 36 hours after HCG triggering | Procedure or surgery | Conservative group, Myomectomy group |
| Embryo transferTransfer of 2 grade 1 embryo on day 2,3 or 5 from oocyte retrieval | Procedure or surgery | Conservative group, Myomectomy group |
Primary outcome
clinical pregnancy rate
Time frame: 4 weeks after embryo transfer
appearance of one or more intrauterine gestational sac by transvaginal ultrasound
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2019.
- Individual participant dataSharing planned: Undecided
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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.
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 Open myomectomy, Gonadotropins and Human chorionic gonadotropin in people with Fibroid Uterus and IVF, 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 4 inclusion and 6 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 5 Apr 2019. 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 (+201005227404, prof.ahmedmaged@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical pregnancy rate (time frame: 4 weeks after embryo transfer). 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 5 Apr 2019.