Growth Hormone Pretreatment in Poseidon Type IV Undergoing ICSI Using Minimal Induction Protocol: A Randomized Controlled Trial
NCT ID: NCT05089344
Last Updated: 2021-10-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
132 participants
INTERVENTIONAL
2021-10-09
2022-12-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Procedure will be done by Prof . Dr Mostafa Fouad . and Lecturer Dr Ebtihal ElTaieb
\* Proper history taking, examination and investigations to:
* exclude other causes of infertility.
* Menstrual history: for assessment of oligo- or anovualtion.
* Medical history: .
* Past history: previous infertility treatment attempts or ovarian hyperstimulation syndrome.
* Obstetric history: for recurrent pregnancy loss.
* Clinical examination, including:
* Arterial blood pressure measurement
* Assessment of hirsutism via modified Ferriman-Gallwey score
* Assessment of alopecia and acne.
* Hormonal profile assessment: basal serum FSH, LH, E2, progesterone, AMH, total serum testosterone, SHBG (for calculation of FAI), DHEA, DHEAS, TSH, prolactin and 24-hour urinary free cortisol (to rule out Cushing's syndrome).
* Semen analysis: to rule out male cause of infertility as teratospermia or azospermia.
* Transvaginal ultrasonography: by the same experienced gynecological sonographer using a Voluson E6 Expert ultrasound machine (General Electric®, Fairfield, CT, USA) for U/S criteria of PCOS, AFC and exclusion any uterine or pelvic pathologies.
* Hysterosalpingography (HSG): to exclude any uterine, tubal or peritoneal abnormalities.
Patients fitting inclusion and exclusion criteria will be randomized to either study groups. A computer generated list via MedCalc ® Software, version 13.2.2 will be used, assigning each participant number to either study groups. Assignment will be done by sequentially numbered, otherwise identical, sealed envelopes (SNOSE), each containing a 2-inch by 2-inch paper with a written code designating the assigned group. These papers will be placed in a folded sheet of aluminum foil fitted inside the envelope. Effort will be taken to assure absence of any detectable differences in size or weight between intervention and control envelopes. Envelopes will be chosen to be opaque and lined inside with carbon paper. Envelopes will be opened sequentially only after writing the subject's tracking information on the envelope so that the carbon paper served as an audit trail.
After enrollment each patient randomly pick an envelope carrying a number, so that patients will not be aware of the assignment (single blind technique), then the controlled ovarian stimulation protocol will be applied according to letter enclosed (A or B) guided by the computer based randomization table.
The patients were randomly assigned to one of the two parallel groups:
* Group A: mild stimulation protocol + growth hormone adjuvant
* Group B: Mild stimulation protocol
Study Interventions: Patients in both groups received mild stimulation protocol:
Controlled ovarian hyperstimulation protocol will be held according to a flexible GnRH antagonist protocol + Clomophine citrate.
Ovarian stimulation will start with a fixed daily dose of 100 mg of Clomiphene citrate daily and recombinant FSH (Gonal-F®) will be started on day 2 of the menstrual cycle at a dose of 150 IU to be adjusted thereafter in a step up fashion every 2 to 4 days according to ovarian response (Kolibianakis et al., 2011).
. For those in the GH group, 8 IU recombinant human GH will be administered starting from Day 14 of the previous cycle Till administration of HCG for ovulation triggering, while those in the control group will receive the same stimulation protocol without the adjuvant GH treatment.
* Follow up TVU/S will be done every other day starting day 6 of stimulation.
* Cetrotide® 0.25 mg will be started when at least one of the following criteria is met: LH \>10 IU/L, presence of a follicle with mean diameter \>12 mm, and serum E2 level \>150 pg/mL and continued until HCG administration.
* When the leading follicle reaches 16 mm, TV U/S will be performed daily till the largest follicle reach a diameter of \>18mm. The maximum duration of rFSH stimulation will not be allowed to exceed day 16.
* OOCYTE RETRIEVAL, FERTILIZATION AND EMBRYO TRANSFER
* Ovarian pick up will be done 36 hours after HCG injection, the transducer will be connected to the ultrasound system. The direction of the guide beam will be checked. The puncturing needle will be connected to an aspiration apparatus attached by a fixation ring to the front and rear ends of the vaginal transducer, thereby defining the direction of puncture corresponding to the guide beam on the ultrasound image. Oocytes will be aspirated using the standard aspiration technique using Wallace® 101 catheter (Smiths medical®, Minnesota, USA) using aspiration pressure 90-100mmHg using flushing technique.
To maximize the number of oocytes recovered, follicular aspiration followed by a single 2-mL flush using embryo culture media. After initial aspiration, follicles were flushed and aspirated three times each with 2 mL flushing medium .
* Intracytoplasmic sperm injection will be performed on metaphase II oocytes using the direct penetration technique. Fertilization results will be assessed 16 to 19 hours after ICSI. Fertilization will be considered normal by the presence of two pronuclei. Oocyte degeneration was identified by collapse of cytoplamic contents and separation from the zona. Failed fertilization will be defined by the absence of the pronuclei.
* Embryo transfer will be performed on day 3 of ICSI, using ultrasound guidance in the midcorporeal part of the uterine cavity using soft Wallace® transfer catheter (Smiths medical®, Minnesota, USA).
* Luteal phase will be supported by natural progesterone in the form of vaginal suppositories 400 mg twice daily starting from the day of oocyte retrieval till pregnancy test.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
mild stimulation protocol + growth hormone adjuvant
Controlled ovarian hyperstimulation protocol will be held according to a flexible GnRH antagonist protocol + Clomophine citrate.
Ovarian stimulation will start with a fixed daily dose of 100 mg of Clomiphene citrate daily and recombinant FSH (Gonal-F®) will be started on day 2 of the menstrual cycle at a dose of 150 IU to be adjusted thereafter in a step up fashion every 2 to 4 days according to ovarian response .
. For those in the GH group, 8 IU recombinant human GH will be administered starting from Day 14 of the previous cycle Till administration of HCG for ovulation triggering
Growth Hormone
growth hormone
Clomiphene citrate daily and recombinant FSH (Gonal-F®)
Clomiphene citrate daily and recombinant FSH (Gonal-F®)
Mild stimuation protocol
Controlled ovarian hyperstimulation protocol will be held according to a flexible GnRH antagonist protocol + Clomophine citrate.
Ovarian stimulation will start with a fixed daily dose of 100 mg of Clomiphene citrate daily and recombinant FSH (Gonal-F®) will be started on day 2 of the menstrual cycle at a dose of 150 IU to be adjusted thereafter in a step up fashion every 2 to 4 days according to ovarian response .
.
Clomiphene citrate daily and recombinant FSH (Gonal-F®)
Clomiphene citrate daily and recombinant FSH (Gonal-F®)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Growth Hormone
growth hormone
Clomiphene citrate daily and recombinant FSH (Gonal-F®)
Clomiphene citrate daily and recombinant FSH (Gonal-F®)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* AFC \<5
* AMH \<1.2 ng/ml
* first IVF trial
Exclusion Criteria
* History of malignant or border line tumors "will be unfit for pregnancy".
* Endocrine or metabolic disorder "affecting quality of oocyte so affecting results".
* Either one of the couple with chromosomal abnormalities "affecting quality of oocyte so affecting results".
* Male partner with severe oligoasthenozoospermia or with teratozoospermia"affecting quality of embryo to be transfered so affecting results".
* Any contraindications to growth hormone, pregnancy (to be ruled out and documented before GH treatment).
* female patients with causes of infertility other than poor ovarian reserve
* females suffering from congenital or acquired uterine anomalies "will affect results of implantation and pregnancy rates "
* females with focal uterine lesions anomalies "will affect results of implantation and pregnancy rates "
* BMI \>30 kg/m2 "affecting quality of oocyte so affecting results".
35 Years
42 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ain Shams Maternity Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Ahmed Mohamed ElSaed Mostafa
principal investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Moustafa Fouad, MD
Role: PRINCIPAL_INVESTIGATOR
Ainshams Maternity Hospital
Ebtihal ElTaieb, MD
Role: STUDY_DIRECTOR
Ainshams Maternity Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
AinShams University
Cairo, , Egypt
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
GH in poor responders
Identifier Type: -
Identifier Source: org_study_id