Post-placental intrauterine device insertion vs puerperal insertion in women undergoing caesarean delivery in Egypt: a 1 year randomised controlled trial.

OBJECTIVE: The aim of the study was to compare 6 month expulsion rates of the copper-bearing intrauterine device (IUD) inserted after delivery of the placenta or at the 6 week postpartum visit in women undergoing caesarean section. METHODS: A parallel-group randomised trial was conducted in an Egyptian university hospital between February 2016 and December 2018. Participants were randomised to either post-placental IUD insertion or IUD insertion at the 6 week postpartum visit. Participants were followed for 12 months. Primary outcomes were IUD expulsion and the proportion of women using an IUD at 6 months. A secondary outcome was the cumulative pregnancy rate at 12 months. RESULTS: Five hundred participants were enrolled in each group. At 6 months the total expulsions were 58/416 (13.9%) in the post-placental group and 4/214 (1.9%) in the puerperal group; IUD use at 6 months was 416/478 (87.0%) in the post-placental group and 214/232 (92.2%) in the puerperal group. Data collected by phone at 12 months showed a higher cumulative pregnancy rate in the puerperal group (84/500, 16.8%) vs the post-placental group (22/500, 4.4%). IUD continuation at 12 months was higher in the post-placental group. CONCLUSION: Participants in the post-placental group had a higher expulsion rate at 6 months, but more IUDs were placed in this group and fewer pregnancies had occurred at 12 months compared with the puerperal group. TRIAL REGISTRATION: Clinicaltrials.gov NCT02679820.

Current contraceptive trends among married Egyptian women: a cross-sectional survey.

OBJECTIVE: The aim of our study was to assess the knowledge and attitudes of married Egyptian women towards the different methods of contraception, examining the role of employment and education in modulating contraceptive behaviour. METHODS: A cross-sectional survey was conducted among 2360 Egyptian women between 15 and 45 years of age who were attending outpatient clinics at a university hospital in Cairo between August 2017 and January 2018. The survey collected sociodemographic data as well as information on education, employment, knowledge about contraceptive methods, current and previous use of contraception, source of family planning advice and side effects from previous contraceptive use. RESULTS: The response rate was 90.2%. Current use of a contraceptive method was 38.3%. The intrauterine device (IUD) was the leading contraceptive method (50.7%), followed by oral contraceptives (OCs) (23.6%). Contraceptive prevalence was significantly higher among working women (p < .001), whose primary choice was OCs, while IUD use was significantly higher among non-working women (p < .001). Contraceptive prevalence was highest among women with secondary school education or higher (41.6%). CONCLUSION: Both employment status and educational level of the surveyed women played a significant role in their contraceptive behaviour.

Which is the best IVF/ICSI protocol to be used in poor responders receiving growth hormone as an adjuvant treatment? A prospective randomized trial.

This open label randomized study aims to define the best protocol to be used with growth hormone in poor responders, with comparison performed to delineate which protocol offers the best cycle outcomes. Two-hundred eighty-seven poor responders were included. The patients were randomly allocated into four groups receiving growth hormone (GH) as an adjuvant therapy added to either long or short agonist protocol, miniflare or antagonist protocols. The short/GH gave significantly lower mean number of oocytes when compared with the long/GH, antagonist/GH and miniflare/GH (4 ± 1.69 versus 5.06 ± 1.83, 4.95 + / = 1.90 and4.98 ± 2.51, respectively p = 0.005). Considering the number of fertilized oocytes, the long/GH showed significantly higher levels than short/GH and antagonist/GH (3.73 ± 1.47 versus 3.02 ± 1.52 and 2.89 ± 1.14, respectively). The main drawback is that it required significantly higher HMG dose and longer duration of stimulation. The long/GH was superior when compared with the three protocols regarding the number of oocytes retrieved and fertilized. But, when considering the clinical pregnancy rates, there was a difference in favor of the long/GH but not reaching a statistically significant value (ClinicalTrials.gov Identifier: NCT01897324).

Randomized trial of combined cabergoline and coasting in preventing ovarian hyperstimulation syndrome during in vitro fertilization/intracytoplasmic sperm injection cycles.

OBJECTIVE: To assess the efficacy of coasting alone, cabergoline alone, or combining both interventions for preventing ovarian hyperstimulation syndrome (OHSS) among high-risk patients undergoing in vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI) treatment cycles. METHODS: The present randomized controlled trial was conducted at the IVF unit of a university hospital in Cairo between October 28, 2013, and July 31, 2015. Patients undergoing IVF/ICSI considered at risk of OHSS were randomly allocated to coasting, cabergoline, or combined coasting and cabergoline. The primary outcome was the rate and degree of symptomatically assessed OHSS. Data were analyzed on a per-protocol basis. RESULTS: There were 100 patients recruited to each group. The occurrence of early OHSS was lowest in the combination group compared with the other groups (P=0.002). CONCLUSION: Combining coasting and cabergoline was associated with a lower OHSS rate compared with either therapy alone. CLINICALTRIALS.GOV: NCT01984320.

The addition of growth hormone adjuvant therapy to the long down regulation protocol in poor responders undergoing in vitro fertilization: Randomized control trial.

OBJECTIVE: to detect the impact of growth hormone (GH) co-treatment to the long down regulation protocol, on the outcomes of IVF/ICSI cycles in poor responders. STUDY DESIGN: this parallel open label randomized control trial was conducted in a university hospital. It included 240 females satisfying the bologna criteria for poor responders. The enrolled females were randomized into 2 groups: A (long/GH) receiving GH adjuvant therapy to the long protocol and group B (control) receiving the long protocol alone. The main outcome measure was the live birth rate (fresh, frozen and cumulative). RESULTS: GH supplementation improved the number of collected oocytes (5.4 ± 1.7 vs. 4.3 ±â€¯2.1), MII oocytes (4.1 ±â€¯2.1 vs. 2.1 ±â€¯1.4), fertilized oocytes (4.0 ±â€¯2.2 vs. 2.0 ±â€¯1.2), transferred embryos (2.4 ±â€¯0.9 vs. 1.6 ±â€¯1.1) and cryopreserved (0.5 ±â€¯0.7 vs. 0.2 ±â€¯0.5). There was no significant difference in the live birth rate whether fresh (17.5% vs. 14.1%) or cumulative (18.3% vs. 14.7%). CONCLUSIONS: Further studies are needed to know the true impact of adding GH to the induction protocols in poor responders, as there was no difference in the live birth rates between the study groups, indicating a lack of trend toward benefit from GH supplementation in poor responders. CLINICAL TRIAL REGISTRATION: NCT02338206.

Intralipid supplementation in women with recurrent spontaneous abortion and elevated levels of natural killer cells.

OBJECTIVE: To investigate the efficacy of intralipid supplementation in women with recurrent spontaneous abortion (RSA) and elevated natural killer cell activity undergoing in vitro fertilization/intracytoplasmic sperm injection. METHODS: Between February 10, 2013, and April 30, 2015, a double-blind randomized controlled study was conducted at a center in Egypt. Women with unexplained secondary infertility, RSA, and elevated levels of natural killer cells (>12%) were enrolled and randomly assigned to receive intralipid (2mL diluted at 20% in 250mL saline) or saline (250mL) infusion on the day of oocyte retrieval using random numbers and sealed envelopes. Patients and attending physicians were masked to group assignment. The infusions were repeated within 1week of a positive pregnancy test and then every 2weeks until the end of the first trimester. The primary outcome was chemical pregnancy 14days after embryo transfer. Analyses were by intention-to-treat. RESULTS: Overall, 296 women were enrolled. Chemical pregnancy was recorded for 84 (58.3%) of 144 women in the intralipid group and 76 (50.0%) of 152 in the control group (P=0.129). CONCLUSION: Intralipid supplementation did not increase frequency of chemical pregnancy. However, findings related to ongoing pregnancy and live birth should be investigated further. ClinicalTrials.gov:NCT01788540.

Addition of growth hormone to the microflare stimulation protocol among women with poor ovarian response.

OBJECTIVE: To assess the efficacy of adding growth hormone (GH) to the microflare stimulation protocol among women with poor ovarian response. METHODS: A parallel, open-label, randomized controlled trial was conducted among patients with poor ovarian response who attended a center in Cairo, Egypt, between July 10 and December 31, 2014. Participants were randomly assigned using a computer program (random block size of 4-8) to undergo the microflare protocol with or without GH. Primary outcomes were the mean numbers of mature oocytes retrieved and fertilized. Analyses were done per protocol: women with cycle cancellations were excluded. RESULTS: The analysis included 72 women in the GH group and 73 in the microflare only group. The mean number of oocytes collected was 7.2±1.5 in the GH group versus 4.7±1.2 in the microflare only group (P<0.001). The mean number of metaphase II oocytes was 5.2±1.2 in the GH group and 2.8±1.0 in the microflare only group (P<0.001). The mean number of fertilized oocytes was higher in the GH group (4.2±1.1) than in the microflare only group (2.5±0.7; P<0.001). CONCLUSION: Addition of GH to the microflare stimulation protocol provided some potential benefits to women with poor ovarian response. However, further studies are required before it could be recommended for routine clinical use. ClinicalTrials.gov:NCT02185326.