Invitro FertilizaionNCT03484611
Prediction of Metaphase II Oocytes According to Different Levels of Serum AMH in Poor Responders Using the Antagonist Protocol
A study testing GnRH antagonist, Gonadotropins and Human chorionic gonadotropin in people with Invitro Fertilizaion, run by Cairo University at 1 site in Egypt.
Trial summary
A multicentric study looked into 179 poor responders who underwent antagonist protocol in ICSI cycles Gonadotrophines is started on day 2 with HMG until the day of HCG administration with starting dose 300IU to 450IU,with no pretreatment with OCPs or progestogens or estrogen. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Invitro Fertilizaion
- What is being tested?
- GnRH antagonist, 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
- 179 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2013to Apr 2018
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 3- On antagonist protocol 4- Poor responder according to ESHRE consensus; in which at least 2 of the following should be present:
- Advanced maternal age (≥ 40 years old) or any other risk factor
- A previous poor ovarian response (cycles cancelled or ≤ 3 oocytes with a conventional protocol)
- An abnormal ovarian reserve test (ORT); antral follicle count (AFC) < 5-7 follicles or anti-mullerian hormone (AMH) ≤0.5- 1.1 ng/ml NB: In the absence of advanced maternal age or abnormal ORT, two previous episodes of poor ovarian response after maximal stimulation patients are also considered poor responders according to ESHRE consensus.
- Presence and Adequate visualization of both ovaries
- Uterine cavity within normal anatomy
Who cannot join
- Any factor which may affect reproductive outcome other than that the patient is a poor responder will be excluded from the study, like:
- Severe male factor .
- Uterine factor (eg: fibroid, polyp, Ashermann, .. etc)
- Immunological disorder (eg: SLE, APS, … etc)
- Thyroid or adrenal dysfunction
- Neoplasia (especially: hypothalamic, pit, ovarian)
Show all 9Show fewer
- Women diagnosed with PCOS according to Rotterdam criteria
- Hydrosalpinx that hasn't been surgically removed or ligated. 8 . Untreated hyperprolactinemia 9 . Abnormal bleeding disorder
- 10.Hepatic or renal dysfunction 11.Hypersenstivity to study medication ( GNRH antagonist) 12.Need to take medication that can influence ovarian stimulation 13.Endometriosis grade 3 or 4 14.Ovarian cyst> 10 cm.
Trial locations and contacts
1 site in 1 country.
Radwa Fahmy, MD contact
Egypt1 site, 1 recruiting
- Recruiting
Kasr Alainy medical school
Cairo, 12111
Ahmed Maged, MD, 01005227404, prof.ahmedmaged@gmail.com
About this study
A multicentric study looked into 179 poor responders who underwent antagonist protocol in ICSI cycles Gonadotrophines is started on day 2 with HMG until the day of HCG administration with starting dose 300IU to 450IU,with no pretreatment with OCPs or progestogens or estrogen.
GNRH antagonist (cetrorelix 0,25mg s.c, cetrotide, serono laboratories, Aubonne Switzerland) is given using flexible protocol, it is given when at least one follicle reaches size 14 mm to prevent premature lutenization ,until the day of hCG administration Ovarian ultrasound scans were performed using a 5.0-9.0 MHZ multi frequency trans vaginal probe to assess the ovarian response till the mature follicles reach18-20mm when hCG administration 10000 IU is given to induce final oocytes maturation , serum E2 is done on day of HCG trigger.
Read more
Trans vaginal ultrasound-guided oocyte retrieval is performed 34-36 hours after hCG injection.
Ultrasound -guided fresh embryo transfer is performed on day 3 or 5 after fertilization.
Progesterone support of luteal phase was commenced on the day of ovum pick up using prontogest 400 mg twice daily.
Read the detailed description
A multicentric study looked into 179 poor responders who underwent antagonist protocol in ICSI cycles
Induction of ovulation cycle:
- Gonadotrophines is started on day 2with HMG(merional, IBSA) ,until the day of HCG administration(choriomon,IBSA10000IU)with starting dose 300IU to 450IU,with no pretreatment with OCPs or progestogens or estrogen.
- GNRH antagonist (cetrorelix 0,25mg s.c, cetrotide, serono laboratories, Aubonne Switzerland) is given using flexible protocol, it is given when at least one follicle reaches size 14 mm to prevent premature lutenization ,until the day of hCG administration
- Ovarian ultrasound scans were performed using a 5.0-9.0 MHZ multi frequency trans vaginal probe (mindrayDP-5) to assess the ovarian response till the mature follicles reach18-20mm when hCG administration 10000 IU is given to induce final oocytes maturation , serum E2 is done on day of HCG trigger.
- Trans vaginal ultrasound-guided oocyte retrieval is performed 34-36 hours after hCG injection.
- Ultrasound -guided fresh embryo transfer is performed on day 3 or 5 after fertilization. . Embryo transfer was performed under abdominal ultrasound guide for proper embryo placement to the mid-uterine cavity. 0ne to three grade 1 or 2 embryos were transferred on day 3 after oocyte retrieval. The quality of the embryos were graded as 1,2,3 (1 being the best and 3 being the worst) based on the number of cells, degree of fragmentation and regularity. Embryo transfer was performed with a Wallace catheter (Smith Medical International Ltd, Hythe, Kent, UK). Progesterone support of luteal phase was commenced on the day of ovum pick up using prontogest 400 mg twice daily (IBSA, institut Biochemique,Switzerland).
- Conditions
- Invitro Fertilizaion
- Being tested
- GnRH antagonist, Gonadotropins, Human chorionic gonadotropin, Embryo transfer, Progesterone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GnRH antagonistDrug
Also called cetrorelix
0,25mg s.c, cetrotide, serono laboratories, Aubonne Switzerland) is given using flexible protocol, it is given when at least one follicle reaches size 14 mm to prevent premature lutenization ,until the day of hCG administration
GonadotropinsDrug
Also called Human menopausal gonadotropin
started on day 2 of the menstrual cycle until the day of HCG administration(choriomon,IBSA10000IU)with starting dose 300IU to 450IU
Human chorionic gonadotropinDrug
Also called HCG
10000 IU is given to induce final oocytes maturation when at least 2 follicles reached 14 mm or more
Embryo transferProcedure or surgery
0ne to three grade 1 or 2 embryos were transferred on day 3 after oocyte retrieval. Embryo transfer was performed with a Wallace catheter (Smith Medical International Ltd, Hythe, Kent, UK)
ProgesteroneDrug
vaginal prontogest 400 mg twice daily
| Study group | Role | What they receive |
|---|---|---|
| AMH < 0.3 ng/ml | Active comparator | Poor ovarian responders according to ESHRE consensus with serum AMH < 0,3 ng/ml Receives: Drug: GnRH antagonist; Drug: Gonadotropins; Drug: Human chorionic gonadotropin; Procedure: Embryo transfer; Drug: Progesterone |
| AMH 0.3 to 0.7 ng/ml | Active comparator | Poor ovarian responders according to ESHRE consensus with serum AMH 0.3 to 0.7 ng/ml Receives: Drug: GnRH antagonist; Drug: Gonadotropins; Drug: Human chorionic gonadotropin; Procedure: Embryo transfer; Drug: Progesterone |
| AMH > 0.7 to 1 ng/ml | Active comparator | Poor ovarian responders according to ESHRE consensus with serum AMH 0.7 to 1 ng/ml Receives: Drug: GnRH antagonist; Drug: Gonadotropins; Drug: Human chorionic gonadotropin; Procedure: Embryo transfer; Drug: Progesterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of the retrieved oocytes
number of oocytes retrieved 34 hours after HCG injection
Measured: 34 hours after HCG injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2018
- Study startJan 2013
- Primary completionApr 2018 (estimated)
- Study completionApr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Invitro FertilizaionStudies 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
- 179 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
- NCT03484611
- Sponsor's protocol ID
- 35
- Status last verified
- Mar 2018
- First submitted
- 26 Mar 2018
- Last updated
- 2 Apr 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 2 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Metaphase II Oocytes According to Different Levels of Serum AMH in Poor Responders Using the Antagonist Protocol
- ClinicalTrials.gov ID
- NCT03484611
- Acronym / sponsor ID
- 35
- Conditions
- Invitro Fertilizaion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 179 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jan 2013 (actual)
- Primary completion
- Apr 2018 (estimated)
- Study completion
- Apr 2018 (estimated)
- First posted
- 2 Apr 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.
A multicentric study looked into 179 poor responders who underwent antagonist protocol in ICSI cycles Gonadotrophines is started on day 2 with HMG until the day of HCG administration with starting dose 300IU to 450IU,with no pretreatment with OCPs or progestogens or estrogen.
GNRH antagonist (cetrorelix 0,25mg s.c, cetrotide, serono laboratories, Aubonne Switzerland) is given using flexible protocol, it is given when at least one follicle reaches size 14 mm to prevent premature lutenization ,until the day of hCG administration Ovarian ultrasound scans were performed using a 5.0-9.0 MHZ multi frequency trans vaginal probe to assess the ovarian response till the mature follicles reach18-20mm when hCG administration 10000 IU is given to induce final oocytes maturation , serum E2 is done on day of HCG trigger.
Trans vaginal ultrasound-guided oocyte retrieval is performed 34-36 hours after hCG injection.
Ultrasound -guided fresh embryo transfer is performed on day 3 or 5 after fertilization.
Progesterone support of luteal phase was commenced on the day of ovum pick up using prontogest 400 mg twice daily.
Detailed description
A multicentric study looked into 179 poor responders who underwent antagonist protocol in ICSI cycles
Induction of ovulation cycle:
- Gonadotrophines is started on day 2with HMG(merional, IBSA) ,until the day of HCG administration(choriomon,IBSA10000IU)with starting dose 300IU to 450IU,with no pretreatment with OCPs or progestogens or estrogen.
- GNRH antagonist (cetrorelix 0,25mg s.c, cetrotide, serono laboratories, Aubonne Switzerland) is given using flexible protocol, it is given when at least one follicle reaches size 14 mm to prevent premature lutenization ,until the day of hCG administration
- Ovarian ultrasound scans were performed using a 5.0-9.0 MHZ multi frequency trans vaginal probe (mindrayDP-5) to assess the ovarian response till the mature follicles reach18-20mm when hCG administration 10000 IU is given to induce final oocytes maturation , serum E2 is done on day of HCG trigger.
- Trans vaginal ultrasound-guided oocyte retrieval is performed 34-36 hours after hCG injection.
- Ultrasound -guided fresh embryo transfer is performed on day 3 or 5 after fertilization. . Embryo transfer was performed under abdominal ultrasound guide for proper embryo placement to the mid-uterine cavity. 0ne to three grade 1 or 2 embryos were transferred on day 3 after oocyte retrieval. The quality of the embryos were graded as 1,2,3 (1 being the best and 3 being the worst) based on the number of cells, degree of fragmentation and regularity. Embryo transfer was performed with a Wallace catheter (Smith Medical International Ltd, Hythe, Kent, UK). Progesterone support of luteal phase was commenced on the day of ovum pick up using prontogest 400 mg twice daily (IBSA, institut Biochemique,Switzerland).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AMH < 0.3 ng/ml | Active comparator | Drug: GnRH antagonist, Drug: Gonadotropins, Drug: Human chorionic gonadotropin, Procedure: Embryo transfer, Drug: ProgesteronePoor ovarian responders according to ESHRE consensus with serum AMH < 0,3 ng/ml |
| AMH 0.3 to 0.7 ng/ml | Active comparator | Drug: GnRH antagonist, Drug: Gonadotropins, Drug: Human chorionic gonadotropin, Procedure: Embryo transfer, Drug: ProgesteronePoor ovarian responders according to ESHRE consensus with serum AMH 0.3 to 0.7 ng/ml |
| AMH > 0.7 to 1 ng/ml | Active comparator | Drug: GnRH antagonist, Drug: Gonadotropins, Drug: Human chorionic gonadotropin, Procedure: Embryo transfer, Drug: ProgesteronePoor ovarian responders according to ESHRE consensus with serum AMH 0.7 to 1 ng/ml |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 3- On antagonist protocol 4- Poor responder according to ESHRE consensus; in which at least 2 of the following should be present:
- Advanced maternal age (≥ 40 years old) or any other risk factor
- A previous poor ovarian response (cycles cancelled or ≤ 3 oocytes with a conventional protocol)
- An abnormal ovarian reserve test (ORT); antral follicle count (AFC) < 5-7 follicles or anti-mullerian hormone (AMH) ≤0.5- 1.1 ng/ml NB: In the absence of advanced maternal age or abnormal ORT, two previous episodes of poor ovarian response after maximal stimulation patients are also considered poor responders according to ESHRE consensus.
- Presence and Adequate visualization of both ovaries
Key exclusion criteria (9 listed)
- Any factor which may affect reproductive outcome other than that the patient is a poor responder will be excluded from the study, like:
- Severe male factor .
- Uterine factor (eg: fibroid, polyp, Ashermann, .. etc)
- Immunological disorder (eg: SLE, APS, … etc)
- Thyroid or adrenal dysfunction
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 |
|---|---|---|
| GnRH antagonistAlso: cetrorelix0,25mg s.c, cetrotide, serono laboratories, Aubonne Switzerland) is given using flexible protocol, it is given when at least one follicle reaches size 14 mm to prevent premature lutenization ,until the day of hCG administration | Drug | AMH 0.3 to 0.7 ng/ml, AMH < 0.3 ng/ml, AMH > 0.7 to 1 ng/ml |
| GonadotropinsAlso: Human menopausal gonadotropinstarted on day 2 of the menstrual cycle until the day of HCG administration(choriomon,IBSA10000IU)with starting dose 300IU to 450IU | Drug | AMH 0.3 to 0.7 ng/ml, AMH < 0.3 ng/ml, AMH > 0.7 to 1 ng/ml |
| Human chorionic gonadotropinAlso: HCG10000 IU is given to induce final oocytes maturation when at least 2 follicles reached 14 mm or more | Drug | AMH 0.3 to 0.7 ng/ml, AMH < 0.3 ng/ml, AMH > 0.7 to 1 ng/ml |
| Embryo transfer0ne to three grade 1 or 2 embryos were transferred on day 3 after oocyte retrieval. Embryo transfer was performed with a Wallace catheter (Smith Medical International Ltd, Hythe, Kent, UK) | Procedure or surgery | AMH 0.3 to 0.7 ng/ml, AMH < 0.3 ng/ml, AMH > 0.7 to 1 ng/ml |
| Progesteronevaginal prontogest 400 mg twice daily | Drug | AMH 0.3 to 0.7 ng/ml, AMH < 0.3 ng/ml, AMH > 0.7 to 1 ng/ml |
Primary outcome
Number of the retrieved oocytes
Time frame: 34 hours after HCG injection
number of oocytes retrieved 34 hours after HCG injection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2018.
- Individual participant dataSharing planned: Undecided
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.
Radwa Fahmy, 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 GnRH antagonist, Gonadotropins and Human chorionic gonadotropin in people with Invitro Fertilizaion, 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 6 inclusion and 9 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 2 Apr 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?
Number of the retrieved oocytes (time frame: 34 hours after HCG injection). 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 2 Apr 2018.