Ovarian Stimulation in ICSINCT04539613
Controlled Ovarian Hyperstimulation (COH) With Sequential HPFSH & HMG Versus Rec-F.S.H Alone in ICSI Cycle
An observational study of Ovarian Stimulation in ICSI, run by Alaa Fouli Gaber Ebrahim at 1 site in Egypt.
Trial summary
despite the large number of papers published on COH protocols comparing the efficiency of different exogenous gonadotropins, no confirmed protocol exists, and it is not quite clear which is superior to the others. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Ovarian Stimulation in ICSI
- What is being tested?
- HPFSH & HMG
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2020to 1 Feb 2021
- 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 20 to 35 years
- Women only
- Adult
Study population: Normal ovulatory function and normal semen analysis
Who may be able to join
- 1-Aged 20-35 yr, male factor, 2-Tubal or unexplained infertility, 3-regular menstruation cycle between 21 and 35 days, 4-Normal function of uterus according to hysterosalpingography, hysteroscopy or transvaginal ultrasonography, 5-Normal ovaries according to transvaginal ultrasonography during past 6 months prior to study and compatible with normal adnexa and 6-Normal ovarian anatomy, and serum FSH level less than 8 IU/l All women showed no recognizable endometriosis according to symptoms and clinical examination in transvaginal ultrasonography or diagnostic laparoscopy. 7-7-All women have a history of unexplained infertility 8-Normal ovulatory function and normal semen analysis according to the World Health Organization criteria .
Who cannot join
- Patients with other ovulation disorders such as hypo and hypergonadotropic, hypogonadism, hyperprolactinemia.
- 2-Thyroid disorders. 3-Ovarian or adrenal neoplasms. 4-Cushing syndrome. 5-previous history of systemic diseases such as endocrine and metabolic disorders.
- 6- Previous history of inappropriate ovarian response to stimulation with gonadotropins (poor responders).
- 7-Prior history of more than 3 unsucce
Trial locations and contacts
1 site in 1 country.
kareem shaheen contact
About this study
despite the large number of papers published on COH protocols comparing the efficiency of different exogenous gonadotropins, no confirmed protocol exists, and it is not quite clear which is superior to the others.
Read the detailed description
, the objective of the current study was to compare the efficacy of 2 different ovarian stimulation protocols, comprising hpFSH, HMG versus R-FSH on oocyte and embryo quality and IVF treatment outcome in patients undergoing IVF or intracytoplasmic sperm injection (ICSI)(4).
- Conditions
- Ovarian Stimulation in ICSI
- Being tested
- HPFSH & HMG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPFSH & HMGDrug
Also called rec-F.S.H
. Various gonadotropin preparations
| Study group | Role | What they receive |
|---|---|---|
| group1 | Group 1(50 case) which will receive hp FSH (fostimon ibsa) (150 IU per ampoule)will be started on day 2 of menstruation and then after six days, HMG (meriofert ibsa), 150 Iu, s.c) will be added Receives: Drug: HPFSH & HMG | |
| group2 | Group 2(50 case) will be treated with recombinant FSH alone (Gonal-F) (150 IU per ampoule) |
What is being measured
The primary outcome is the main question the study is designed to answer.
fertility outcomes (pregnancy rate, abortion and live birth rate) in IVF patients.
(pregnancy rate, abortion and live birth rate) in IVF patients.
Measured: 5months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2020
- Study start1 Sep 2020 (estimated)
- Primary completion1 Jan 2021 (estimated)
- Study completion1 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ovarian Stimulation in ICSIStudies 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
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alaa Fouli Gaber Ebrahim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Alaa Fouli Gaber Ebrahim, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04539613
- Sponsor's protocol ID
- COH in ICSI
- Status last verified
- Aug 2020
- First submitted
- 31 Aug 2020
- Last updated
- 7 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kamel RM. The onset of human parturition. Arch Gynecol Obstet. 2010 Jun;281(6):975-82. doi: 10.1007/s00404-010-1365-9. Epub 2010 Feb 3.
PubMed 20127346
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Controlled Ovarian Hyperstimulation (COH) With Sequential HPFSH & HMG Versus Rec-F.S.H Alone in ICSI Cycle
- ClinicalTrials.gov ID
- NCT04539613
- Acronym / sponsor ID
- COH in ICSI
- Conditions
- Ovarian Stimulation in ICSI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Alaa Fouli Gaber EbrahimUniversity, hospital or other
- Study start
- 1 Sep 2020 (estimated)
- Primary completion
- 1 Jan 2021 (estimated)
- Study completion
- 1 Feb 2021 (estimated)
- First posted
- 7 Sep 2020 (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.
despite the large number of papers published on COH protocols comparing the efficiency of different exogenous gonadotropins, no confirmed protocol exists, and it is not quite clear which is superior to the others.
Detailed description
, the objective of the current study was to compare the efficacy of 2 different ovarian stimulation protocols, comprising hpFSH, HMG versus R-FSH on oocyte and embryo quality and IVF treatment outcome in patients undergoing IVF or intracytoplasmic sperm injection (ICSI)(4).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group1 | – | Drug: HPFSH & HMGGroup 1(50 case) which will receive hp FSH (fostimon ibsa) (150 IU per ampoule)will be started on day 2 of menstruation and then after six days, HMG (meriofert ibsa), 150 Iu, s.c) will be added |
| group2 | – | –Group 2(50 case) will be treated with recombinant FSH alone (Gonal-F) (150 IU per ampoule) |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Normal ovulatory function and normal semen analysis
Key inclusion criteria (1 listed)
- 1-Aged 20-35 yr, male factor, 2-Tubal or unexplained infertility, 3-regular menstruation cycle between 21 and 35 days, 4-Normal function of uterus according to hysterosalpingography, hysteroscopy or transvaginal ultrasonography, 5-Normal ovaries according to transvaginal ultrasonography during past 6 months prior to study and compatible with normal adnexa and 6-Normal ovarian anatomy, and serum FSH level less than 8 IU/l All women showed no recognizable endometriosis according to symptoms and clinical examination in transvaginal ultrasonography or diagnostic laparoscopy. 7-7-All women have a history of unexplained infertility 8-Normal ovulatory function and normal semen analysis according to the World Health Organization criteria .
Key exclusion criteria (4 listed)
- Patients with other ovulation disorders such as hypo and hypergonadotropic, hypogonadism, hyperprolactinemia.
- 2-Thyroid disorders. 3-Ovarian or adrenal neoplasms. 4-Cushing syndrome. 5-previous history of systemic diseases such as endocrine and metabolic disorders.
- 6- Previous history of inappropriate ovarian response to stimulation with gonadotropins (poor responders).
- 7-Prior history of more than 3 unsucce
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 |
|---|---|---|
| HPFSH & HMGAlso: rec-F.S.H. Various gonadotropin preparations | Drug | group1 |
Primary outcome
fertility outcomes (pregnancy rate, abortion and live birth rate) in IVF patients.
Time frame: 5months
(pregnancy rate, abortion and live birth rate) in IVF patients.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2020.
- Background: PubMed 20127346Kamel RM. The onset of human parturition. Arch Gynecol Obstet. 2010 Jun;281(6):975-82. doi: 10.1007/s00404-010-1365-9. Epub 2010 Feb 3.
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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.
kareem shaheen contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Stimulation in ICSI, run by Alaa Fouli Gaber Ebrahim 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 1 inclusion and 4 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 7 Sep 2020. 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 Amna Abdel sabour (01092405752, mannoon1991@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fertility outcomes (pregnancy rate, abortion and live birth rate) in IVF patients. (time frame: 5months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04539613, which also lists 1 linked publication.
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 7 Sep 2020.