الفهرس 
Introduction and aim of the studyOnly 14 pages are availabe for public view
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Abstract
The present study is a randomized (non-blind)-controlled clinical trial
that included 102 PCOS patients planned for ICSI. It was conducted in
Sohag university hospital & Sohag city ART centers, during the period from
May 1, 2022 to May 1, 2023. The recruited cases were fulfilling the inclusion
criteria and accepting to participate in the study.
The recruited patients were divided into two groups. group I; included
53 patients who received pretreatment with dydrogestrone during the cycle
preceding the ICSI cycle in a daily dose of 20 mg/ day starting 10 days before
the presumed onset of menses. group II included 49 patients who received
pretreatment in the form of combined estradiol valerate 2 mg /d plus
dydrogestrone 10mg /day for10 days.
Candidates were subjected to fixed GnRH antagonist protocol with coadministration of gonadotrophin from day 3 of the induced menses cycle &
GnRh antagonist from the 6th day of stimulation till the day of trigger or coadministered gonadotrophins with 20mg dydrogesterone from day 3 of
induced menses cycle till day of trigger (PPOS protocol). After triggering
ovulation & oocyte retrieval, ICSI was conducted & Freeze All in both arms
was done then frozen embryos were transferred next cycle after
endometrial preparation.
The objective of the current study was to evaluate the role of
dydrogestrone vs combined estradiol valerate and dydrogestrone[Type here]
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pretreatment in the improvement of intra cytoplasmic sperm injection (ICSI)
pregnancy outcome, in patient with PCOS.
The mean age of the studied cases was 27.88 years & 93 patients
(about 91%) were younger than 35 years. There is no significant difference
between the mean age of cases in group I and group II (29 ±5 years VS 28
±4 years respectively, P= 0.4). 9 cases were ≥ 35 years 2 of them only
were ≥40 years (1 aged 40 years in group II & one aged 42years in group
I.
Parity of the patients varied from 0 to 3. Most of the studied cases
were nulligravida (76-77%).The two grups of patients did not differ
significantly in their parity (P=0.9).
There is no significant difference between the means BMI of the
patients studied (27 ±5 VS 28 ± 3 kg/m2 in groups I & II respectively, P=0.8)
.29 of the recruited cases (28.4%) have BMI ≥ 30 kg/square meter; 15 in
group I & 14 in group II..Of these, only 3 patients had BMI ≥ 35 kg/square
meter (1 in group I & 2 in group II).
The duration of infertility ranged from 1-20 years with a mean of 5.45
±2.08 & 5.29 ±3.74 years in group I and group II respectively (P= 0.4).The
duration of infertility was of 5-10 years in 44 patients (43%), 23 0f them
belonged to group I & 21 cases belonged to group II. The duration of infertility
was 11-15 years in 5 cases (4.9%). Only 1 case had infertility for 17 years &
1 had infertility for 20 years.[Type here]
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No abnormalities detected at previous Hysteroscopy that was
conducted before recruitment in the study in 12 cases & previous
laparoscopic ovarian drilling was conducted in 8 patients (4 from each
group).
Antral follicle count (AFC) as assessed by transvaginal sonography
after the pretreatment and before ovulation induction- ranges from 12-30,
with a mean value of 22 vs 24 in groups I & II respectively (P=0.012).
The mean value of AMH in the studied cases was 6.36 ng/mL. The
mean value (±SD) of AMH showed no significant difference in the mean
(±SD) of the studied groups (6.45±1.95 vs 6.28±1.45 in groups I and II
respectively, P=0.9). 96 cases (about 94%) had AMH ≥ 3.5ng/mL (50
cases in group I vs 46 cases in group II. There was Only 3 cases with AMH
level of ≥ 9ng/mL (2 in group I & 1 in group II), with the upper limit of AMH
was 16.2ng/mL
Although all cases of PRL level were within normal range, yet the
mean level was higher in group I than in group II (14.4±5.2 VS 12.2± 4.1
respectively, P value =0.031)
In the stimulation cycle of the studied cases:
- No significant difference between group I and group II regarding HMG
stimulation duration in days (10±1 VS 10±1, P=0.4). The duration of
stimulation ranged from 8-12 days, and 95 cases (93%) needed > 8 days of[Type here]
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stimulation.70 cases (68.6%) needed ≥ 10 days of stimulation (38 cases
i.e.71.7% in group I and 32 cases i.e.65.3% in group II).
- No significant difference between study groups regarding the total
dose of HMG in both groups (2,044 ± 787 vs 2,030 ± 557 IU in group I & II
respectively, P=0.5). The mean total dose of HMG is lower in group II than
group I.
-In 100 cases (98%), the follicles were >14 mm at the time of
recruitment (100/102 =98%). 70 cases i.e. 68.6% (39 in group I & 31 in group
II) had more than 20 follicles. No statistically significant differences were
found in the mean no of follicles >14mm at the trigger day between the two
studied groups (24±5 & 24±4, P=0.5).
-The mean number of retrieved oocytes was 22.16 & it was higher in
group II than group I with no significant difference (23 ± 5 vs 21 ± 5
respectively, P=0.4). Also, the proportion of mature oocytes (M2 oocytes) per
retrieval shows no significant difference between the 2 groups (18±5 VS
18±4, P= 0.8) & ranged from 6 to 33.
The maturation index (which is the number of normal M2 ooctes per
total number of normal oocytes collected) was 82.35% . All cases in our study
have maturation index ≥ 50%.
-No significant difference among the study groups after stimulation
regarding embryo number (6 ±3 VS 6.±2 in groups I & II respectively, P=0.2).[Type here]
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The mean number of embryos in all cases was about 6 and ranged from 1
to 20.
-1-3 embryos were transferred (mean 2 embryos). Two embryos were
transferred in 79 cases (77.5%) and 3 embryos were transferred in 22 cases
(21.6%).
- No patients experienced moderate or severe ovarian
hyperstimulation syndrome (OHSS) in both study groups
The effect of pretreatment on pregnancy outcome was as follows:
-Of the cases studied, the conception rate was 54% (55/102), CPR was
about 46%(47/102), The implantation rate was about 30% (67/225), the rate
of twinning was 20% (20/102).
-There were no significant differences in the conception rate
(26/53)[49.05%] vs.29/49 [59.15%], P=0.4), clinical pregnancy rate (22/53
[41.5%] vs. 25/49 [51.05%], P=0.4 & implantation rate (27.12 vs 32.71%, P-
0.65) between Duphastone pretreatment group & combined estradiol
valerate and duphastone pretreatment group. Only 1 case of ectopic
pregnancy was diagnosed that belonged to group I.
Successive Estradiol valerate and duphaston pretreatment (group II)
seems to enhance ICSI outcome, as it was associated with higher
conception rate, implantation rate &CPR but the difference does not reach
significant difference.[Type here]
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The multiple pregnancy rate (twins only) was (45.5% vs 40% in groups
I & II respectively, P=0.5). So, the rate of twinning was higher in group I VS
group II .
Conclusions
Pretreatment with dydrogestone or combined Estradiol valerate and
dydrogestone in PCOS treated for ICSI, have the advantages of scheduling
ICSI cycles & synchronization of the follicles. In addition, compared to ICSI
cycles without pretreatment they offer the benefits of having higher preantral
follicle count and high AMH levels before starting induction & high oocyte
yield and high M2 oocytes and maturation index in the induction cycle.
Moreover, they boost the conception rate, implantation rate and clinical
pregnancy rate & prevent cases of OHSS.
Compared with other forms of pretreatment in ICSI cycles for PCOS,
our protocols give higher AFC, AMH levels , higher oocyte yield and M2
oocytes and maturation index. Pregnancy and implantation rates are
comparable. No reported cases of OHSS with our protocols, which is not the
case with other pretreatment protocols.
The protocol of pretreatment using combined estradiol valerate and
dydrogestrone compared to the the protocol of dydrogestrone pretreatment
in our study, offers the advantages of assuring significantly higher mean
AFC, together with less gonadotrophin dose consumed on induction thus
decreasing the financial burden on the patients & as well ensuring more
oocyte yield. The combined protocol also improves ICSI outcomes of PCOS
patients with less multiple pregnancy rate.