Invitro FertilizationNCT03457233
The Impact of Body Weight on Reproductive Outcomes in Poor Ovarian Responders in ICSI Cycles
A study testing Gonadotropins, GNRH antagonist and Human chorionic gonadotropin Chorimon in people with Invitro Fertilization, run by Cairo University at 1 site in Egypt.
Trial summary
Induction of ovulation cycle: 1. Gonadotrophines is started on day 2 with HMG(merional, IBSA) ,until the day of HCG administration(choriomon,IBSA10000IU) with starting dose 300 to 450iu. 2. Read more about this study
- Who is it for?
- Ages 20 to 44 years, women only
- Conditions the study is for
- Invitro Fertilization
- What is being tested?
- Gonadotropins, GNRH antagonist and Human chorionic gonadotropin Chorimon
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 185 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Jan 2015to Mar 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 44 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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 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 assessed with HSG, hysteroscopy and TVUS
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 15Show fewer
- Women diagnosed with PCOS according to Rotterdam criteria
- Hydrosalpinx that hasn't been surgically removed or ligated.
- Untreated hyperprolactinemia
- Abnormal bleeding disorder
- Hepatic or renal dysfunction
- Hypersenstivity to study medication ( GNRH antagonist)
- Need to take medication that can influence ovarian stimulation
- Endometriosis grade 3 or 4
- 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
Official title: The Impact of Overweight and Obesity on Reproductive Outcomes in Poor Ovarian Responders in ICSI Cycles
Induction of ovulation cycle:
- Gonadotrophines is started on day 2 with HMG(merional, IBSA) ,until the day of HCG administration(choriomon,IBSA10000IU) with starting dose 300 to 450iu.
- 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.Serum E2 level is done on day of HCG trigger.
- Trans vaginal ultrasound-guided oocyte retrieval is performed 34-36 hours after hCG injection
- Progesterone vaginal tablets (Prontogest,IBSA) are administrated 400mg twice daily as luteal support from the day of oocytes retrieval.
- Ultrasound -guided fresh embryo transfer is performed on day 2 or 3 after fertilization.
- Serum hCG assessment to detect pregnancy is performed at 14 days after embryo transfer .if positive(chemical pregnancy) ,women undergo trans -vaginal ultrasonography 2 weeks after, to confirm fetal pulsations as well as number of gestational sacs (clinical pregnancy).
- The implantation rate is calculated as the number of viable embryos divided by the number of transferred embryos multiplied by 100
Read the detailed description
Induction of ovulation cycle:
- Gonadotrophines is started on day 2 with HMG(merional, IBSA) ,until the day of HCG administration(choriomon,IBSA10000IU) with starting dose 300 to 450iu.
- 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.Serum E2 level is done on day of HCG trigger.
- Trans vaginal ultrasound-guided oocyte retrieval is performed 34-36 hours after hCG injection
- Progesterone vaginal tablets (Prontogest,IBSA) are administrated 400mg twice daily as luteal support from the day of oocytes retrieval.
- Ultrasound -guided fresh embryo transfer is performed on day 2 or 3 after fertilization.
- Serum hCG assessment to detect pregnancy is performed at 14 days after embryo transfer .if positive(chemical pregnancy) ,women undergo trans -vaginal ultrasonography 2 weeks after, to confirm fetal pulsations as well as number of gestational sacs (clinical pregnancy).
- The implantation rate is calculated as the number of viable embryos divided by the number of transferred embryos multiplied by 100
- Conditions
- Invitro Fertilization
- Being tested
- Gonadotropins, GNRH antagonist, Human chorionic gonadotropin Chorimon, Natural progesterone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GonadotropinsDrug
Also called Human menopausal gonadotropin
- Gonadotrophines is started on day 2 with HMG(merional, IBSA) ,until the day of HCG administration
GNRH antagonistDrug
Also called cetrorelix
cetrorelix 0,25mg s.c 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
Human chorionic gonadotropin ChorimonDrug
Also called HCG
10000 IU of HCG are given intramuscular when 2 or more mature follicles reach 18 - 20 mm
Natural progesteroneDrug
Also called prontogest
400 mg vaginal tablets twice daily from the day of ovum pick up till HCG tesing
| Study group | Role | What they receive |
|---|---|---|
| Normal weight | Active comparator | 18.5- 24.9 kg/m2 Receives: Drug: Gonadotropins; Drug: GNRH antagonist; Drug: Human chorionic gonadotropin Chorimon; Drug: Natural progesterone |
| Overweight | Active comparator | BMI 25-29.9 kg/m2 Receives: Drug: Gonadotropins; Drug: GNRH antagonist; Drug: Human chorionic gonadotropin Chorimon; Drug: Natural progesterone |
| Obese | Active comparator | BMI ≥ 30 kg/m2 Receives: Drug: Gonadotropins; Drug: GNRH antagonist; Drug: Human chorionic gonadotropin Chorimon; Drug: Natural progesterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical pregnancy rate
appearance of intrauterine gestational sac by transvaginal ultrasound
Measured: 4 weeks after HCG triggering
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2018
- Study start3 Jan 2015
- Primary completionMar 2018 (estimated)
- Study completionMar 2018 (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 Invitro FertilizationStudies 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
- 185 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, Principal investigator, professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03457233
- Sponsor's protocol ID
- 31
- Status last verified
- Mar 2018
- First submitted
- 25 Feb 2018
- Last updated
- 7 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Maged AM, Fahmy RM, Rashwan H, Mahmood M, Hassan SM, Nabil H, Hany A, Lotfy R, Lasheen YS, Dahab S, Darwish M. Effect of body mass index on the outcome of IVF cycles among patients with poor ovarian response. Int J Gynaecol Obstet. 2019 Feb;144(2):161-166. doi: 10.1002/ijgo.12706. Epub 2018 Nov 26.
PubMed 30407618
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Overweight and Obesity on Reproductive Outcomes in Poor Ovarian Responders in ICSI Cycles
- ClinicalTrials.gov ID
- NCT03457233
- Acronym / sponsor ID
- 31
- Conditions
- Invitro Fertilization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 185 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 3 Jan 2015 (actual)
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 7 Mar 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.
Induction of ovulation cycle:
- Gonadotrophines is started on day 2 with HMG(merional, IBSA) ,until the day of HCG administration(choriomon,IBSA10000IU) with starting dose 300 to 450iu.
- 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.Serum E2 level is done on day of HCG trigger.
- Trans vaginal ultrasound-guided oocyte retrieval is performed 34-36 hours after hCG injection
- Progesterone vaginal tablets (Prontogest,IBSA) are administrated 400mg twice daily as luteal support from the day of oocytes retrieval.
- Ultrasound -guided fresh embryo transfer is performed on day 2 or 3 after fertilization.
- Serum hCG assessment to detect pregnancy is performed at 14 days after embryo transfer .if positive(chemical pregnancy) ,women undergo trans -vaginal ultrasonography 2 weeks after, to confirm fetal pulsations as well as number of gestational sacs (clinical pregnancy).
- The implantation rate is calculated as the number of viable embryos divided by the number of transferred embryos multiplied by 100
Detailed description
Induction of ovulation cycle:
- Gonadotrophines is started on day 2 with HMG(merional, IBSA) ,until the day of HCG administration(choriomon,IBSA10000IU) with starting dose 300 to 450iu.
- 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.Serum E2 level is done on day of HCG trigger.
- Trans vaginal ultrasound-guided oocyte retrieval is performed 34-36 hours after hCG injection
- Progesterone vaginal tablets (Prontogest,IBSA) are administrated 400mg twice daily as luteal support from the day of oocytes retrieval.
- Ultrasound -guided fresh embryo transfer is performed on day 2 or 3 after fertilization.
- Serum hCG assessment to detect pregnancy is performed at 14 days after embryo transfer .if positive(chemical pregnancy) ,women undergo trans -vaginal ultrasonography 2 weeks after, to confirm fetal pulsations as well as number of gestational sacs (clinical pregnancy).
- The implantation rate is calculated as the number of viable embryos divided by the number of transferred embryos multiplied by 100
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal weight | Active comparator | Drug: Gonadotropins, Drug: GNRH antagonist, Drug: Human chorionic gonadotropin Chorimon, Drug: Natural progesterone18.5- 24.9 kg/m2 |
| Overweight | Active comparator | Drug: Gonadotropins, Drug: GNRH antagonist, Drug: Human chorionic gonadotropin Chorimon, Drug: Natural progesteroneBMI 25-29.9 kg/m2 |
| Obese | Active comparator | Drug: Gonadotropins, Drug: GNRH antagonist, Drug: Human chorionic gonadotropin Chorimon, Drug: Natural progesteroneBMI ≥ 30 kg/m2 |
Who may qualify
- Ages
- 20 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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 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 assessed with HSG, hysteroscopy and TVUS
Key exclusion criteria (15 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 |
|---|---|---|
| GonadotropinsAlso: Human menopausal gonadotropin1) Gonadotrophines is started on day 2 with HMG(merional, IBSA) ,until the day of HCG administration | Drug | Normal weight, Obese, Overweight |
| GNRH antagonistAlso: cetrorelixcetrorelix 0,25mg s.c 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 | Normal weight, Obese, Overweight |
| Human chorionic gonadotropin ChorimonAlso: HCG10000 IU of HCG are given intramuscular when 2 or more mature follicles reach 18 - 20 mm | Drug | Normal weight, Obese, Overweight |
| Natural progesteroneAlso: prontogest400 mg vaginal tablets twice daily from the day of ovum pick up till HCG tesing | Drug | Normal weight, Obese, Overweight |
Primary outcome
clinical pregnancy rate
Time frame: 4 weeks after HCG triggering
appearance of 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 7 Mar 2018.
- Derived from this study: PubMed 30407618Maged AM, Fahmy RM, Rashwan H, Mahmood M, Hassan SM, Nabil H, Hany A, Lotfy R, Lasheen YS, Dahab S, Darwish M. Effect of body mass index on the outcome of IVF cycles among patients with poor ovarian response. Int J Gynaecol Obstet. 2019 Feb;144(2):161-166. doi: 10.1002/ijgo.12706. Epub 2018 Nov 26.
- 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.
Radwa Fahmy, MD contact
Ahmed Maged 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 Gonadotropins, GNRH antagonist and Human chorionic gonadotropin Chorimon in people with Invitro Fertilization, 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 2 inclusion and 15 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 Mar 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?
clinical pregnancy rate (time frame: 4 weeks after HCG triggering). 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 NCT03457233, 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 Mar 2018.